{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "139360", "product_res_number": "Z-0598-2016", "event_date_initiated": "2013-04-22", "event_date_posted": "2016-01-19", "recall_status": "Terminated", "event_date_terminated": "2018-04-17", "res_event_number": "71924", "product_code": "HAW", "k_numbers": [ "K092467" ], "product_description": "Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments.\n\nThe BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.", "code_info": "1) Model\t22035\t,\tVVC NAVIGATION SOFTWARE CRANIAL 5.0\t,\tSerial Numbers: 22035-103911-004\t, 22035-103953-001\t, 22035-103977-001\t, 22035-103982-002\t, 22035-103987-001\t, 22035-103988-001\t, 22035-104566-001\t;  2) Model\t22040\t,\tVV NAVIGATION SOFTWARE CRANIAL 4.0\t,\tSerial Numbers:  22040/18820\t, 22040/21370\t, 22040/26909\t, 22040/36997\t, 22040-103675-006\t, 22040-103687-009\t, 22040-103710-001\t, 22040-103942-008\t, 22040-103974-011\t, 22040-104067-001\t, 22040-104072-001\t, 22040-104114-001\t, 22040-104148-001\t, 22040-104151-001\t, 22040-104505-001\t, 22040-104542-001\t, 22040-104545-001\t, 22040-104614-005\t, 22040-123772-001\t;  3) Model\t22040-02\t,\tVV NAV SW CRANIAL 7.8.1 (ANY PLATFORM)\t,\tSerial Number: \t000000002600509001\t;  4) Model\t22040-11\t,\tUPDATE VV NAV SW CRANIAL 7.9.1 FROM 7.9\t,\tSerial Numbers:  000000007665811001\t, 000000007801111004\t, 000000007801111005\t, 000000007801111006\t, 000000007801111007\t, 000000007801111008\t, 000000007801111009\t, 000000007808711004\t, 000000007808711007\t, 000000007808711008\t, 000000007837611010\t, 000000007847411007\t, 000000007865211004\t, 000000007865211005\t, 000000007942211004\t, 000000007942211008\t, 000000007942211010\t, 000000007950411001\t, 000000007950411004\t, 000000007950411007\t, 000000007950411010\t, 000000007956611005\t, 000000007956611010\t, 000000007956611017\t, 000000007965011001\t, 000000007965011006\t, 000000007965011007\t, 000000007980111001\t, 000000007980111002\t, 000000007980111003\t, 000000007980111004\t, 000000007980111005\t, 000000007980111006\t, 000000007980111007\t, 000000008000111003\t, 000000008000111006\t, 000000008000111007\t, 000000008012411001\t, 000000008012411003\t, 000000008012411008\t, 000000008026011002\t, 000000008026011003\t, 000000008036811002\t, 000000008036811006\t, 000000008036811007\t, 000000008036811008\t, 000000008036911002\t, 000000008036911004\t, 000000008036911005\t, 000000008046111002\t, 000000008046111005\t, 000000008073511003\t, 000000008073511007\t, 000000008086811001\t, 000000008106711001\t, 000000008114111004\t, 000000008129711004\t, 000000008129711005\t, 000000008129711006\t, 000000008133311001\t, 000000008133311002\t, 000000008143111002\t, 000000008143111003\t, 000000008143111004\t, 000000008157411005\t, 000000008157411007\t, 000000008167811005\t, 000000008167811008\t, 000000008167811012\t, 000000008167811014\t, 000000008167811015\t, 000000008167811016\t, 000000008180811001\t, 000000008180811008\t, 000000008180811009\t, 000000008180811010\t, 000000008180811011\t, 000000008181011002\t, 000000008208411002\t, 000000008230111001\t, 000000008230111002\t, 000000008230111009\t, 000000008230111013\t, 000000008230111015\t, 000000008230111022\t, 000000008230111024\t, 000000008230111025\t, 000000008230211001\t, 000000008230211002\t, 000000008230211008\t, 000000008230211017\t, 000000008230211020\t, 000000008230211025\t, 000000008230211030\t, 000000008230311006\t, 000000008230311014\t, 000000008230311015\t, 000000008230311018\t, 000000008230411003\t, 000000008230411005\t, 000000008230411009\t, 000000008230411010\t, 000000008230411012\t, 000000008230411016\t, 000000008230411021\t, 000000008230411024\t, 000000008230411029\t, 000000008230411030\t, 000000008230411031\t, 000000008230411032\t, 000000008242111002\t, 000000008242111003\t, 000000008242111005\t, 000000008242611001\t, 000000008242611002\t, 000000009168012001\t;  5) Model\t22040B\t,\tVV NAVIGATION SOFTWARE CRANIAL7.5.0\t,\tSerial Numbers:  05-48916-22040B\t, 05-51803-22040B\t, 05-52149-22040B\t, 22040B/46911\t;  6) Model\t22040C\t,\tVV NAVIGATION SOFTWARE CRANIAL 7.6.0\t,\tSerial Numbers:  05-63659-22040C\t, 05-63669-22040C\t, 05-66754-22040C\t, 06-79914-22040C\t;  7) Model\t22040D\t,\tVV NAVIGATION SW CRANIAL 7.7\t,\tSerial Numbers:  06-84302-22040D\t, 06-85635-22040D\t, 06-88801-22040D\t;  8) Model\t22040E\t,\tVV NAVIGATION SW CRANIAL 7.8\t,\tSerial Numbers:  06-101594-22040E\t, 06-103819-22040E\t, 06-108132-22040E\t, 07-102189-22040E\t, 07-106354-22040E\t, 07-108464-22040E\t, 07-109071-22040E\t, 07-109217-22040E\t, 07-110114-22040E\t, 07-112255-22040E\t, 07-112347-22040E\t, 07-113858-22040E\t, 07-114331-22040E\t, 07-117343-22040E\t, 07-118687-22040E\t, 07-118695-22040E\t, 07-119019-22040E\t, 07-119599-22040E\t, 07-120231-22040E\t, 07-120842-22040E\t, 07-122228-22040E\t, 07-123321-22040E\t, 07-124014-22040E\t, 07-126723-22040E\t, 07-128644-22040E\t, 07-129197-22040E\t, 07-129354-22040E\t, 07-130356-22040E\t;  9) Model\t22040F\t,\tVV NAVIGATION SW CRANIAL 7.8.1\t,\tSerial Numbers:  000000001242908001\t, 000000001275408001\t, 000000001305408001\t, 000000001346908001\t, 000000001386608001\t, 000000001402808001\t, 000000001506308001\t, 000000001516208001\t, 000000001548508001\t, 000000001611208001\t, 000000001644608001\t, 000000001716308001\t, 000000001730608001\t, 000000001832508001\t, 000000001832608001\t, 000000001867508001\t, 000000001869408001\t, 000000001924908001\t, 000000001943208001\t, 000000001944708001\t, 000000002054708001\t, 000000002082108001\t, 000000002179709001\t, 000000002352209001\t, 000000002401209001\t, 000000002540709001\t, 000000002540809001\t, 000000002565609001\t, 000000002565809001\t, 000000002610309001\t, 000000002921409001\t, 000000002945709001\t, 000000003057109001\t, 000000003171909001\t, 000000003331709001\t, 000000003433809001\t, 000000003446909001\t, 3540908001\t, 3557608001\t, 6039008001\t, 6110908001\t, 6303008001\t, 6406408001\t, 6594408001\t, 6655308001\t, 6757308001\t, 6983608001\t, 07-133796-22040F\t, 07-134724-22040F\t, 07-135062-22040F\t, 07-135413-22040F\t, 07-136068-22040F\t, 07-136871-22040F\t, 07-137864-22040F\t, 07-138500-22040F\t, 07-138954-22040F\t, 07-138987-22040F\t, 07-139009-22040F\t, 07-139027-22040F\t, 07-139037-22040F\t, 07-139083-22040F\t, 07-139412-22040F\t, 07-139955-22040F\t, 07-141837-22040F\t, 07-144111-22040F\t, 07-145211-22040F\t, 07-146009-22040F\t, 08-148434-22040F\t, 08-149705-22040F\t, 08-153066-22040F\t, 08-154083-22040F\t, 08-155770-22040F\t, 08-156023-22040F\t, 08-156226-22040F\t, 08-156570-22040F\t, 08-157148-22040F\t, 08-157972-22040F\t;  10) Model\t22040H\t,\tVV NAVIGATION SW CRANIAL 7.9.1\t,\tSerial Numbers:  000000004274913001\t, 000000008413811001\t;  11) Model\t22043\t,\tUPDATE VV NAV SWCRANIAL 6.0 TO 6.01\t,\tSerial Numbers:  07-135238-22043\t, 22043/1194\t;  12) Model\t22204-02\t,\tKOLIBRI NAV SW CRAN 2.6.1 (ANY PLATFORM)\t,\tSerial Number: \t000000003102809001\t;  13) Model\t22204B\t,\tKOLIBRI NAVIGATION SW CRANIAL 2.5.0\t,\tSerial Number: \t06-86477-22204B\t;  14) Model\t22204C\t,\tKOLIBRI NAVIGATION SW CRANIAL 2.6.0\t,\tSerial Numbers:  06-100679-22204C\t, 06-104941-22204C\t, 07-112890-22204C\t, 07-114630-22204C\t, 07-116967-22204C\t, 07-123214-22204C\t, 07-128684-22204C\t, 07-129055-22204C\t, 07-133191-22204C\t, 07-133265-22204C\t, 15) Model\t22204D\t,\tKOLIBRI NAVIGATION SW CRANIAL 2.6.1\t,\tSerial Numbers:  000000001120208001\t, 000000001125508001\t, 000000001178108001\t, 000000001291308001\t, 000000001343608001\t, 000000001362808001\t, 000000001671208001\t, 000000002019108001\t, 000000002108909001\t, 000000002219709001\t, 000000002308509001\t, 000000002494309001\t, 6259008001\t, 6381208001\t, 6662908001\t, 6898208001\t, 07-134523-22204D\t, 07-135013-22204D\t, 07-135592-22204D\t, 07-141778-22204D\t, 07-142020-22204D\t, 07-149290-22204D\t, 08-148598-22204D\t, 08-152171-22204D\t, 08-153392-22204D\t, 08-153694-22204D\t, 08-154014-22204D\t, 08-154473-22204D\t, 08-157303-22204D\t, 08-157669-22204D\t;  16) Model\t22204E\t,\tKOLIBRI NAVIGATION SW CRANIAL 2.7\t,\tSerial Number: \t000000003211909001\t;  17) Model\t22207\t,\tCRANIAL ESSENTIAL NAV SW 1.0\t,\tSerial Numbers: \t000000002787409001\t,  000000002796409001\t, 000000002811509001\t, 000000002867009001\t, 000000002906409001\t, 000000002930409001\t, 000000003058009001\t, 000000003220409001\t, 000000003224109001\t, 000000003546309001\t, 000000003576409001\t, 000000003680909001\t, 000000003738509001\t, 000000003982409001\t, 000000003990809001\t, 000000004154809001\t, 000000004494710001\t, 000000004535510001\t, 000000004622210001\t, 000000004636910001\t, 000000004804710001\t, 000000004910010001\t, 000000004923210001\t, 000000005074410001\t, 000000005078110001\t, 000000005100710001\t, 000000005153810001\t, 000000005353810001\t, 000000005354110001\t, 000000005427710001\t, 000000005453410001\t, 000000005607210001\t, 000000005651510001\t, 000000005668710001\t, 000000005710010001\t, 000000005736910001\t, 000000005838110001\t, 000000006077510001\t, 000000006148710001\t, 000000006179010001\t, 000000006306910001\t, 000000006339910001\t, 000000006363010001\t, 000000006726411001\t, 000000006949311001\t, 000000007053911001\t, 000000007076211001\t, 000000007146511001\t, 000000007172711001\t, 000000007302311001\t, 000000007418911001\t;  18) Model\t22207A\t,\tCRANIAL ESSENTIAL NAVIGATION SW 1.0.1\t,\tSerial Number: \t000000007678411001\t;  19) Model\t22208\t,\tCRANIAL UNLIMITED NAV SW 1.0\t,\tSerial Numbers: \t000000002958709001\t, 000000003668009001\t, 000000004574810001\t, 000000004694310001\t, 000000005096210001\t, 000000005278010001\t, 000000005728710001\t, 000000006119610002\t, 000000006119610003\t, 000000006119610004\t, 000000006119610005\t, 000000006271410001\t, 000000006654910001\t, 000000006694611001\t, 000000006786911001\t;  20) Model\t22208-11\t,\tUPDATE CRANIAL UNLIMITED 1.0.1 FROM 1.0\t,\tSerial Numbers: \t000000007719311001\t, 000000007757911001\t, 000000007775111001\t, 000000007801311002\t, 000000007801311005\t, 000000007808811004\t, 000000007814811001\t, 000000007814811002\t, 000000007830611001\t, 000000007830611003\t, 000000007837811001\t, 000000007837811003\t, 000000007837811004\t, 000000007847611002\t, 000000007856311001\t, 000000007856311003\t, 000000007856311005\t, 000000007856311006\t, 000000007865011004\t, 000000007865011005\t, 000000007865011006\t, 000000007891211001\t, 000000007891211002\t, 000000007891211003\t, 000000007891211004\t, 000000007891211005\t, 000000007927911001\t, 000000007927911002\t, 000000007927911003\t, 000000007927911005\t, 000000007927911009\t, 000000007928011001\t, 000000007928011002\t, 000000007928011003\t, 000000007942511002\t, 000000007942511003\t, 000000007942511005\t, 000000007942511006\t, 000000007942511013\t, 000000007942511014\t, 000000007942511016\t, 000000007942511018\t, 000000007950711002\t, 000000007950711004\t, 000000007950711005\t, 000000007950711009\t, 000000007950711011\t, 000000007957111012\t, 000000007980311001\t, 000000007980311002\t, 000000007980311004\t, 000000007980311006\t, 000000007980311010\t, 000000007980311011\t, 000000007980311012\t, 000000008012711002\t, 000000008012711004\t, 000000008025711001\t, 000000008025711002\t, 000000008025711003\t, 000000008037311001\t, 000000008037411001\t, 000000008037411002\t, 000000008037411003\t, 000000008037411005\t, 000000008045711002\t, 000000008045711004\t, 000000008059111001\t, 000000008059211001\t, 000000008074511004\t, 000000008074511006\t, 000000008074511008\t, 000000008074511009\t, 000000008074511011\t, 000000008074511013\t, 000000008074511014\t, 000000008074511016\t, 000000008074611001\t, 000000008074611002\t, 000000008087011002\t, 000000008087011004\t, 000000008087011008\t, 000000008087011009\t, 000000008087011010\t, 000000008087011011\t, 000000008087211001\t, 000000008106811001\t, 000000008106811003\t, 000000008106811004\t, 000000008114411002\t, 000000008114411005\t, 000000008114411009\t, 000000008114411012\t, 000000008129911003\t, 000000008129911004\t, 000000008129911005\t, 000000008129911006\t, 000000008129911007\t, 000000008129911008\t, 000000008134911002\t, 000000008134911003\t, 000000008134911004\t, 000000008134911005\t, 000000008134911006\t, 000000008134911007\t, 000000008134911008\t, 000000008134911009\t, 000000008134911010\t, 000000008134911011\t, 000000008134911016\t, 000000008143611001\t, 000000008143611002\t, 000000008143611004\t, 000000008143611006\t, 000000008143611007\t, 000000008143611008\t, 000000008143611010\t, 000000008143611011\t, 000000008143611012\t, 000000008143611016\t, 000000008143611018\t, 000000008143611019\t, 000000008143611020\t, 000000008143611024\t, 000000008143611026\t, 000000008143611027\t, 000000008150011001\t, 000000008150011003\t, 000000008150011004\t, 000000008150011005\t, 000000008150011006\t, 000000008157811001\t, 000000008157811002\t, 000000008157811003\t, 000000008157811007\t, 000000008157811008\t, 000000008157811009\t, 000000008157811010\t, 000000008157811012\t, 000000008168311002\t, 000000008168311005\t, 000000008168311006\t, 000000008168311007\t, 000000008168311008\t, 000000008168311009\t, 000000008168311010\t, 000000008168311011\t, 000000008181511003\t, 000000008181511004\t, 000000008208911001\t, 000000008208911004\t, 000000008208911005\t, 000000008222511001\t, 000000008222511002\t, 000000008222511003\t, 000000008222511005\t, 000000008222511006\t, 000000008222511008\t, 000000008222511009\t, 000000008222511010\t, 000000008222511011\t, 000000008222511013\t, 000000008222511014\t, 000000008230711001\t, 000000008230711004\t, 000000008230711005\t, 000000008230711006\t, 000000008230711007\t, 000000008230711008\t, 000000008242711001\t, 000000008242711005\t, 000000008242711006\t, 000000008242711008\t, 000000008242711009\t, 000000008242711010\t, 000000008242711011\t, 000000008242711012\t, 000000008242711013\t, 000000008242711015\t, 000000008242711016\t, 000000008242711019\t, 000000008242711020\t, 000000008242711023\t, 000000008242711024\t, 000000008242711025\t, 000000008242711026\t, 000000008242711027\t, 000000008242711028\t, 000000008242711029\t, 000000008242711031\t, 000000008242711033\t, 000000008242711034\t, 000000008242711035\t, 000000008242711036\t, 000000008242711038\t, 000000008242711041\t, 000000008242711042\t, 000000008242711043\t, 000000008242711044\t, 000000008277511001\t, 000000008352911001\t, 000000009167712001\t, 000000009167812001\t, 000000009167912001\t, 000000009239412001\t, 000000009359612001\t, 000000009408712001\t, 000000009408812001\t;  21) Model\t22208A\t,\tCRANIAL UNL NAVIGATION SW 1.0.1\t,\tSerial Numbers: \t000000001287412001\t, 000000003539513001\t, 000000004457713001\t, 000000008293111001\t, 000000008471411001\t, 000000008489611001\t;  22) Model\t22214\t,\tCRANIAL NAVIGATION SW 2.1\t,\tSerial Numbers: \t000000007467211001\t, 000000007489111001\t, 000000007494611001\t, 000000007495311001\t, 000000007505911001\t, 000000007516811001\t, 000000007516911001\t, 000000007545411001\t, 000000007572811001\t, 000000007576811001\t, 000000007578311001\t, 000000007604811001\t, 000000007605711001\t, 000000007605811001\t, 000000007605911001\t, 000000007683111001\t, 000000007695511001\t, 000000007735211001\t, 000000007773611001\t, 000000007777511001\t, 000000007802011001\t, 000000007840911001\t, 000000007872611001\t, 000000007899411001\t, 000000007936111001\t, 000000007954111001\t, 000000007960411001\t, 000000007973911001\t, 000000008063011001\t, 000000008067111001\t, 000000008100511001\t, 000000008111511001\t, 000000008165111001\t, 000000008189511001\t, 000000008210511001\t, 000000008245011001\t, 000000008245111001\t, 000000008260011001\t, 000000008290111001\t, 000000008370011001\t, 000000008431811001\t, 000000008441811001\t;  23) Model\t22214-01\t,\tUPDATE CRANIAL 2.1.1 FROM 2.1\t,\tSerial Numbers: \t000000008574211001\t, 000000008741911001\t, 000000008861011001\t, 000000008980412001\t, 000000009122512001\t, 000000009199812001\t, 000000009237012001\t, 000000009283712001\t, 000000009283812001\t, 000000009283912001\t, 000000009284012001\t, 000000009284112001\t, 000000009316312001\t, 000000009363312001\t, 000000009422712001\t, 000000009437312001\t, 000000009437412001\t, 000000009437512001\t, 000000009437612001\t, 000000009481412001\t, 000000009861512001\t;  24) Model\t22214-01A\t,\tUPD CRANIAL 2.1.1 W/ DATA LOAD FROM 2.1\t,\tSerial Numbers: \t000000000239512001\t, 000000000246112001\t, 000000000605512001\t, 000000000605814001\t, 000000000797312001\t, 000000000815712001\t, 000000001221412001\t, 000000001866612001\t, 000000001866712001\t, 000000002099012001\t, 000000002698513001\t, 000000004417413001\t, 000000009530014001\t;  25) Model\t22214-01B\t,\tUPD CRANIAL 2.1.1 W/ DATA LOAD FROM 2.1\t,\tSerial Numbers: \t000000000051714001\t, 000000005104313001\t, 000000006146515001\t, 000000006146615001\t, 000000006146715001\t, 000000006146815001\t, 000000007622015001\t, 000000009289414001\t;  26) Model\t22214A\t,\tCRANIAL NAVIGATION SW 2.1.1\t,\tSerial Numbers: \t000000000052612001\t, 000000000052712001\t, 000000000055912001\t, 000000000157012001\t, 000000008553411001\t, 000000008598111001\t, 000000008615711001\t, 000000008624811001\t, 000000008674211001\t, 000000008700211001\t, 000000008714811001\t, 000000008715911001\t, 000000008766711001\t, 000000008795711001\t, 000000008844011001\t, 000000008848411001\t, 000000008861911001\t, 000000008874011001\t, 000000008902511001\t, 000000008947212001\t, 000000008968312001\t, 000000009013812001\t, 000000009022712001\t, 000000009043912001\t, 000000009053712001\t, 000000009106912001\t, 000000009133112001\t, 000000009133612001\t, 000000009134012001\t, 000000009168512001\t, 000000009306012001\t, 000000009342012001\t, 000000009382912001\t, 000000009395512001\t, 000000009401412001\t, 000000009461012001\t, 000000009505812001\t, 000000009551212001\t, 000000009559212001\t, 000000009573412001\t, 000000009647912001\t, 000000009654412001\t, 000000009654612001\t, 000000009745412001\t, 000000009763112001\t, 000000009787112001\t, 000000009788212001\t, 000000009816112001\t, 000000009816212001\t, 000000009819512001\t, 000000009867212001\t, 000000009885512001\t, 000000009926512001\t, 000000009944112001\t, 000000009951112001\t, 000000009964612001\t;  27) Model\t22214B\t,\tCRANIAL NAVIGATION SW 2.1.1\t,\tSerial Numbers: \t000000000240112001\t, 000000000240212001\t, 000000000254712001\t, 000000000353512001\t, 000000000385712001\t, 000000000385812001\t, 000000000405512001\t, 000000000406612001\t, 000000000496312001\t, 000000000503212001\t, 000000000520312001\t, 000000000546512001\t, 000000000574812001\t, 000000000587912001\t, 000000000615712001\t, 000000000623212001\t, 000000000681112001\t, 000000000709312001\t, 000000000709412001\t, 000000000712112001\t, 000000000725312001\t, 000000000726312001\t, 000000000760512001\t, 000000000792812001\t, 000000000813012001\t, 000000000848912001\t, 000000000871612001\t, 000000000959612001\t, 000000001014212001\t, 000000001132612001\t, 000000001168512001\t, 000000001196612001\t, 000000001213712001\t, 000000001235712001\t, 000000001324112001\t, 000000001341012001\t, 000000001354912001\t, 000000001362412001\t, 000000001382112001\t, 000000001384512001\t, 000000001634612001\t, 000000001634712001\t, 000000001635012001\t, 000000001645912001\t, 000000001695412001\t, 000000001705512001\t, 000000001752412001\t, 000000001782812001\t, 000000001783612001\t, 000000001804712001\t, 000000001823412001\t, 000000001850912001\t, 000000001873512001\t, 000000001882512001\t, 000000001936612001\t, 000000001938712001\t, 000000001938812001\t, 000000002045412001\t, 000000002059512001\t, 000000002104112001\t, 000000002179412001\t, 000000002240312001\t, 000000002323212001\t, 000000002346312001\t, 000000002360212001\t, 000000002368012001\t, 000000002370912001\t, 000000002371012001\t, 000000002380812001\t, 000000002401612001\t, 000000002421712001\t, 000000002422812001\t, 000000002424312001\t, 000000002433512001\t, 000000002444812001\t, 000000002508012001\t, 000000002580412001\t, 000000002610013001\t, 000000002615112001\t, 000000002662913001\t, 000000002682613001\t, 000000002705213001\t, 000000002714613001\t, 000000002788513001\t, 000000002815713001\t, 000000002967013001\t, 000000002988213001\t, 000000003009213001\t, 000000003053413001\t, 000000003059013001\t, 000000003067613001\t, 000000003071813001\t, 000000003158813001\t, 000000003223813001\t, 000000003273213001\t, 000000003286913001\t, 000000003297813001\t, 000000003300613001\t, 000000003302213001\t, 000000003332213001\t, 000000003356613001\t, 000000003379513001\t, 000000003382713001\t, 000000003409613001\t, 000000003465613001\t, 000000003489313001\t, 000000003633013001\t, 000000003633113001\t, 000000003643713001\t;  28) Model\t22214C\t,\tCRANIAL NAVIGATION SW 2.1\t,\tSerial Numbers: \t000000000034814001\t, 000000000034914001\t, 000000000059214001\t, 000000000266114001\t, 000000001118214001\t, 000000001320614001\t, 000000001496814001\t, 000000001855614001\t, 000000001933214001\t, 000000001949014001\t, 000000001950314001\t, 000000002549514001\t, 000000003648014001\t, 000000003671614001\t, 000000003816414001\t, 000000003818813001\t, 000000003818913001\t, 000000003819013001\t, 000000003848013001\t, 000000003877714001\t, 000000003896213001\t, 000000003953413001\t, 000000003954013001\t, 000000003978813001\t, 000000003978913001\t, 000000003979013001\t, 000000003979113001\t, 000000003979213001\t, 000000004058613001\t, 000000004058713001\t, 000000004062414001\t, 000000004069313001\t, 000000004069413001\t, 000000004089813001\t, 000000004153413001\t, 000000004161613001\t, 000000004334713001\t, 000000004406013001\t, 000000004439913001\t, 000000004468913001\t, 000000004469013001\t, 000000004469113001\t, 000000004486313001\t, 000000004486413001\t, 000000004486513001\t, 000000004486613001\t, 000000004486713001\t, 000000004504313001\t, 000000004538314001\t, 000000004545113001\t, 000000004612413001\t, 000000004663813001\t, 000000004663913001\t, 000000004709113001\t, 000000004783814001\t, 000000004859613001\t, 000000004859713001\t, 000000004887513001\t, 000000004988313001\t, 000000005006513001\t, 000000005066313001\t, 000000005153913001\t, 000000005173713001\t, 000000005173813001\t, 000000005173913001\t, 000000005274015001\t, 000000005275513001\t, 000000005429413001\t, 000000005447613001\t, 000000005504713001\t, 000000005555513001\t, 000000005571213001\t, 000000005614113001\t, 000000005614213001\t, 000000005632713001\t, 000000005655613001\t, 000000005734813001\t, 000000005749813001\t, 000000005783213001\t, 000000005783313001\t, 000000005809913001\t, 000000005843413001\t, 000000005858813001\t, 000000005933613001\t, 000000005933713001\t, 000000006082113001\t, 000000006082213001\t, 000000006089613001\t, 000000006110313001\t, 000000006133613001\t, 000000006260615001\t, 000000006264013001\t, 000000006388913001\t, 000000006389013001\t, 000000006389113001\t, 000000006389213001\t, 000000006389313001\t, 000000006389413001\t, 000000006389513001\t, 000000006421115001\t, 000000006501613001\t, 000000006642913001\t, 000000006678013001\t, 000000006727313001\t, 000000006787613001\t, 000000006876713001\t, 000000006914715001\t, 000000006963413001\t, 000000006963513001\t, 000000006965115001\t, 000000006986013001\t, 000000006986113001\t, 000000007070313001\t, 000000007070413001\t, 000000007104213001\t, 000000007122413001\t, 000000007133613001\t, 000000007133713001\t, 000000007152313001\t, 000000007183813001\t, 000000007222213001\t, 000000007275913001\t, 000000007276013001\t, 000000007298113001\t, 000000007335813001\t, 000000007386913001\t, 000000007505713001\t, 000000007582914001\t, 000000007597214001\t, 000000007615214001\t, 000000007679014001\t, 000000007695914001\t, 000000007739514001\t, 000000007748814001\t, 000000007778815001\t, 000000007778915001\t, 000000007779015001\t, 000000007779115001\t, 000000007779215001\t, 000000007845614001\t, 000000007855114001\t, 000000007864215001\t, 000000007864315001\t, 000000007864415001\t, 000000007864515001\t, 000000007864615001\t, 000000007864715001\t, 000000007887514001\t, 000000007887614001\t, 000000007931114001\t, 000000007952814001\t, 000000008108414001\t, 000000008146114001\t, 000000008169214001\t, 000000008214914001\t, 000000008252814001\t, 000000008252914001\t, 000000008253014001\t, 000000008253114001\t, 000000008270014001\t, 000000008288414001\t, 000000008288514001\t, 000000008345715001\t, 000000008352914001\t, 000000008387414001\t, 000000008412014001\t, 000000008442114001\t, 000000008442214001\t, 000000008451814001\t, 000000008465514001\t, 000000008528214001\t, 000000008569214001\t, 000000008576714001\t, 000000008679414001\t, 000000008795114001\t, 000000008921914001\t, 000000008930314001\t, 000000008952114001\t, 000000008968714001\t, 000000008968814001\t, 000000008968914001\t, 000000008984714001\t, 000000009086514001\t, 000000009148214001\t, 000000009192514001\t, 000000009212114001\t, 000000009379914001\t, 000000009440114001\t, 000000009468614001\t, 000000009506614001\t, 000000009533714001\t, 000000009659414001\t, 000000009688014001\t, 000000009780614001\t, 000000009780714001\t, 000000009990514001\t, 000000009990614001\t;  29) Model\t71000\t,\tVV SOFTWARE UPGRADE CRANIAL 3.X TO 6.01\t,\tSerial Numbers: \t71000/21628\t, 71000-103744-001\t, 71000-103745-002\t, 05-49480-71005\t;  30) Model\t71006\t,\tUPG VV CRANIAL 6.01 TO CRANIAL 7.0.X\t,\tSerial Numbers: \t000000002899209001\t, 000000003143809001\t, 000000004297109001\t, 6032908001\t, 05-50560-71006\t, 05-52155-71006\t, 08-148612-71006\t;  31) Model\t71008\t,\tUPG VV CRANIAL 7.0 TO CRANIAL 7.5\t,\tSerial Number: \t000000004384709001\t;  32) Model\t71011\t,\tUPG CRA ESSENTIAL 1.0 TO UNLIMIMITED 1.0\t,\tSerial Numbers: \t000000004150309001\t, 000000004441110001\t;  33) Model\t71011A\t,\tUPGRADE CRANIAL ESS 1.0.1 TO UNL 1.0.1\t,\tSerial Numbers: \t000000007678511001\t, 000000008548411001\t;  34) Model\t71012\t,\tUPGRADE VV CRANIAL 7.9 TO UNLIMITED 1.0\t,\tSerial Number: \t000000004337709001\t;  35) Model\t71012A\t,\tUPGRADE VV CRANIAL 7.9.1 TO UNL 1.0.1\t,\tSerial Numbers: \t000000005629513001\t, 000000005629613001\t, 000000005629713001\t, 000000005629913001\t, 000000005676213001\t, 000000005676313001\t, 000000005769113001\t, 000000005809113001\t;  36) Model\t71013\t,\tUPG KOLIBRI CRANIAL 2.7 TO ESSENTIAL 1.0\t,\tSerial Number: \t000000002811109001\t;  37) Model\t71017\t,\tUPG TO CRAN 2.x FROM CRAN UNLIMITED 1.0\t,\tSerial Numbers: \t000000000005412001\t,  000000000060612001\t, 000000000108312001\t, 000000000108412001\t, 000000000108512001\t, 000000000251912001\t, 000000000316012001\t, 000000000388112001\t, 000000000721512001\t, 000000000722012001\t, 000000001002812001\t, 000000001015412001\t, 000000001114112001\t, 000000001114212001\t, 000000001279512001\t, 000000001291612001\t, 000000001311912001\t, 000000001336712001\t, 000000001358812001\t, 000000001511812001\t, 000000001652012001\t, 000000001757512001\t, 000000002034512001\t, 000000002777513001\t, 000000002788013001\t, 000000002911513001\t, 000000002958813001\t, 000000003056913001\t, 000000003067913001\t, 000000003094513001\t, 000000003151913001\t, 000000003187813001\t, 000000003242113001\t, 000000003538413001\t, 000000007545311001\t, 000000007587511001\t, 000000007678011001\t, 000000007725111001\t, 000000007888511001\t, 000000008050311001\t, 000000008084411001\t, 000000008231511001\t, 000000008264411001\t, 000000008283511001\t, 000000008377711001\t, 000000008444611001\t, 000000008529511001\t, 000000008579211001\t, 000000008579311001\t, 000000008579411001\t, 000000008676811001\t, 000000008676911002\t, 000000008855711001\t, 000000009001312001\t, 000000009002812001\t, 000000009079812001\t, 000000009146112001\t, 000000009162712001\t, 000000009168712001\t, 000000009187212001\t, 000000009208512001\t, 000000009411312001\t, 000000009470312001\t, 000000009470412001\t, 000000009484312001\t, 000000009599812001\t, 000000009632012001\t, 000000009652512001\t, 000000009760312001\t, 000000009840212001\t, 000000009931412001\t, 000000009931512001\t;  38) Model\t71017A\t,\tUPG TO CRAN 2.x FROM CRAN UNLIMITED 1.0\t,\tSerial Numbers: \t000000001088214001\t, 000000002036614001\t, 000000002632314001\t, 000000002855614001\t, 000000003113714001\t, 000000003113814001\t, 000000003531414001\t, 000000003603714001\t, 000000003753014001\t, 000000003753114001\t, 000000003924713001\t, 000000003979114001\t, 000000004041513001\t, 000000004111013001\t, 000000004152813001\t, 000000004152913001\t, 000000004321813001\t, 000000004321913001\t, 000000004322013001\t, 000000004519013001\t, 000000004591513001\t, 000000004813913001\t, 000000004866313001\t, 000000004866413001\t, 000000005172113001\t, 000000005650913001\t, 000000006367713001\t, 000000006367813001\t, 000000006662513001\t, 000000006752013001\t, 000000006894213001\t, 000000006894313001\t, 000000006909613001\t, 000000007311115001\t, 000000007365613001\t, 000000007432713001\t, 000000007514713001\t, 000000007624313001\t, 000000007657214001\t, 000000007704815001\t, 000000007765214001\t, 000000008248514001\t, 000000008508414001\t, 000000009319814001\t, 000000009378914001\t, 000000009466914001\t;  39) Model\t71051\t,\tUPD VV CRANIAL 7.5.X TO 7.6.X\t,\tSerial Number: \t000000002382609001\t;  40) Model\t71053\t,\tUPD VV CRANIAL 7.6.X TO CRANIAL7.7.X\t,\tSerial Number: \t06-88103-71053\t;  41) Model\t71056\t,\tUPD VV CRANIAL 7.7.X TO CRANIAL7.8.X\t,\tSerial Numbers: \t000000001425108001\t, 000000001462008001\t, 000000003671509001\t, 000000009258012001\t;  42) Model\t71063\t,\tUPG KOL CRANIAL 2.5.X TO CRANIAL 2.6.X\t,\tSerial Number: \t07-111143-71063\t;  43) Model\t71067\t,\tUPDATE VV NAV SW CRANIAL 7.8 TO 7.9\t,\tSerial Numbers: \t000000003270709001\t, 000000003428909001\t, 000000004577510001\t;  44) Model\t71067A\t,\tUPDATE VV NAV SW CRANIAL 7.8 TO 7.9.1\t,\tSerial Numbers: \t000000000253112001\t, 000000000452712001\t, 000000001446312001\t, 000000001533312001\t, 000000001708612001\t, 000000002492312001\t, 000000004691813001\t, 000000009147012001\t, 000000009537312001\t, 000000009641812001\t, 000000009653312001\t;  45) Model\t71069\t,\tUPD KOLIBRI NAV SW CRANIAL 2.6 TO 2.7\t,\tSerial Numbers: \t000000003189109001\t,  000000003189209001\t, 000000003200109001\t, 000000003288809001\t, 000000003498009001\t, 000000004323109001\t, 000000004576710001\t, 000000006333310001\t, 000000006333410001\t;  46) Model\t71075\t,\tUPG CRA ESS 1.0 FROM ANY PREV. KOL SW\t,\tSerial Number: \t000000005026310001\t;  47) Model\t71076\t,\tUPG VV CRA 7.0 FROM ANY PREV. VV CRA SW\t,\tSerial Number: \t000000007742711001\t;  48) Model\t71077\t,\tUPG CRA UNL 1.0 FROM VV CRA 7.X\t,\tSerial Numbers: \t000000005437910001\t, 000000005587010001\t, 000000006351510001\t;  49) Model\t71077A\t,\tUPGRADE CRANIAL UNL 1.0.1 FROM VV 7.X\t,\tSerial Numbers: \t000000002989913001\t,  000000002990013001\t, 000000007676711001\t, 000000008849411001\t, 000000009150612001\t;  50) Model\t71086\t,\tUPG TO CRANIAL NAV SW 2.X FROM ANY PREV\t,\tSerial Numbers: \t000000000110212001\t, 000000000268812001\t, 000000000268912001\t, 000000000269112001\t, 000000000306812001\t, 000000000317512001\t, 000000000420912001\t, 000000000564112001\t, 000000000627612001\t, 000000000776012001\t, 000000000837012001\t, 000000001030812001\t, 000000001157712001\t, 000000001489112001\t, 000000001510112001\t, 000000001694212001\t, 000000002957213001\t, 000000004002213001\t, 000000007487311001\t, 000000007494511001\t, 000000007561011001\t, 000000007584811001\t, 000000007754211001\t, 000000007766011001\t, 000000007832511001\t, 000000007896911001\t, 000000008147311001\t, 000000008292611001\t, 000000008312911001\t, 000000008537511001\t, 000000008610611001\t, 000000008623211001\t, 000000008626411001\t, 000000008655511001\t, 000000008796311001\t, 000000008891611001\t, 000000009025612001\t, 000000009232112001\t, 000000009301712001\t, 000000009388712001\t, 000000009537112001\t, 000000009737712001\t, 000000009737712002\t, 000000009737712003\t, 000000009856112001\t, 000000009900812001\t, 000000009904912001\t, 000000009988512001\t, 000000009991312001\t, 000000009991412001\t;  51) Model\t71086A\t,\tUPG TO CRANIAL NAV SW 2.X FROM ANY PREV\t,\tSerial Numbers: \t000000002036914001\t, 000000002344114001\t, 000000004470113001\t, 000000004507013001\t, 000000004507113001\t, 000000004918215001\t, 000000005094113001\t, 000000005658713001\t, 000000006162913001\t, 000000007326413001\t, 000000007513413001\t, 000000007870114001\t, 000000008813214001\t, 000000009479914001\t;  52) Model\t71088\t,\tUPGR TO CRANIAL NAV SW 2.X 11-02-18JUG2\t,\tSerial Numbers: \t000000007578911001\t, 000000007626611001\t;  53) Model\t71093\t,\tGEN UPG CRANIAL NAV SW FOR CURVE\t,\tSerial Numbers: \t000000000350812001\t, 000000000619012001\t, 000000000645412001\t, 000000000676712001\t, 000000000957112001\t, 000000001091112001\t, 000000001726912001\t, 000000001727012001\t, 000000002541512001\t, 000000002583812001\t, 000000002765713001\t, 000000003236413001\t, 000000003237213001\t, 000000009412112001\t, 000000009626512001\t, 000000009669712001\t, 000000009700112001\t;  54) Model\t71093A\t,\tGEN UPG CRANIAL NAV SW FOR CURVE/KICK\t,\tSerial Numbers: \t000000000494614001\t, 000000001210114001\t, 000000001239214001\t, 000000002580914001\t, 000000003754914001\t, 000000003828313001\t, 000000004239713001\t, 000000004315913001\t, 000000004591713001\t, 000000004606413001\t, 000000004785513001\t, 000000004881313001\t, 000000005430113001\t, 000000005602113001\t, 000000005602213001\t, 000000005658813001\t, 000000005658913001\t, 000000005669013001\t, 000000005982813001\t, 000000006044113001\t, 000000006044213001\t, 000000006395013001\t, 000000006395113001\t, 000000006501913001\t, 000000006643113001\t, 000000006738213001\t, 000000006878013001\t, 000000007095113001\t, 000000007095213001\t, 000000007223613001\t, 000000007248815001\t, 000000007377813001\t, 000000007487813001\t, 000000007641214001\t, 000000007641314001\t, 000000007819514001\t, 000000007844914001\t, 000000007931414001\t, 000000008021914001\t, 000000008260014001\t, 000000008296214001\t, 000000008319314001\t, 000000008454614001\t, 000000008500114001\t, 000000008795614001\t, 000000008860614001\t, 000000008860714001\t, 000000008878214001\t, 000000009480014001\t;  55) Model\t71096\t,\tUPG TO CRAN 2.x CURVE FROM CRAN UNL 1.0\t,\tSerial Numbers: \t000000000239112001\t,  000000000239212001\t, 000000000239312001\t, 000000000330112001\t, 000000000789212001\t, 000000000789312001\t, 000000000998012001\t, 000000001081912001\t, 000000001186712001\t, 000000001231712001\t, 000000001352512001\t, 000000001620512001\t, 000000001706812001\t, 000000001749112001\t, 000000001895012001\t, 000000002056312001\t, 000000002098912001\t, 000000002235012001\t, 000000002235112001\t, 000000002360412001\t, 000000002696813001\t, 000000002777313001\t, 000000002777413001\t, 000000002878213001\t, 000000003057013001\t, 000000003261813001\t, 000000003314513001\t, 000000003450613001\t, 000000003450713001\t, 000000003450813001\t, 000000003602013001\t, 000000003609213001\t, 000000003609313001\t, 000000003609413001\t, 000000003666113001\t, 000000009232212001\t, 000000009389912001\t, 000000009530112001\t, 000000009764012001\t;  54) Model\t71096A\t,\tUPG TO CRAN 2.x CURVE FROM CRAN UNL 1.0\t,\tSerial Numbers: \t000000001634614001\t, 000000002290314001\t, 000000003924813001\t, 000000003960613001\t, 000000003960713001\t, 000000004303913001\t, 000000004533313001\t, 000000005397113001\t, 000000005503813001\t, 000000005535413001\t, 000000006656213001\t, 000000006894413001\t, 000000006894513001\t, 000000006941613001\t, 000000007196713001\t, 000000007365713001\t, 000000007595914001\t, 000000007927114001\t, 000000008479114001\t, 000000008543914001\t, 000000009189414001\t, 000000009189514001\t, 000000009485314001\t, 000000009564714001\t, 000000009564814001\t, 000000009908214001\t, 000000009987114001\t;  55) Model\t71097\t,\tUPG TO CRAN 2.X CURVE FROM CRAN 2.X STD\t,\tSerial Numbers: \t000000001620412001\t, 000000001662512001\t, 000000003087513001\t, 000000003756313001\t, 000000008548011001\t;  56) Model\t71097A\t,\tUPG TO CRAN 2.X CURVE FROM CRAN 2.X STD\t,\tSerial Numbers: \t000000001887414001\t, 000000002536114001\t, 000000004403613001\t, 000000005779713001\t, 000000006658513001\t, 000000007168513001\t, 000000007181513001\t, 000000007418613001\t, 000000007707214001\t, 000000008465014001", "firm_fei_number": "3002619595", "recalling_firm": "Brainlab AG", "address_1": "Olof-Palme-Strasse 9 9 olof-palme-strasse", "city": "Munich", "country": "Germany", "reason_for_recall": "Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.", "root_cause_description": "Software in the Use Environment", "action": "The firm, Brainlab AG, sent out a \"Field Safety Notice / Product Notification\" CAPA-20130417-000315 Brainlab Cranial Navigation System: Effect of setup on overall navigation accuracy for all versions of software on 4/22/2013 and an update on 5/29/2015.\n\n- From April 22, 2013 has been distributed via email to the consignees.\n- UPDATE from May 29, 2015 was distributed via email to the medical users.\n\nAn active reply by the consignees will be followed, if necessary via further different communication media.\n\nFIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter describes the product, problem and actions to be taken. The customers were instructed to adhere to the measures described in document Measures to Improve Cranial Navigation Accuracy in the Product Notification letter when using the Brainlab Cranial Navigation System.\n\nBrainlab is requesting that \n\n1. Existing potentially affected customers receive this Product Notification Letter.\n2. These customers receive the attached supplement to the Instructions for Use regarding the Brainlab Cranial Navigation System in hardcopy version as an amendment to their current User Manuals. Tentative planned timeline for availability: June 2013\n\nAdditionally to advise the appropriate personnel working in your department of the content of Product Notification letter.\n\nIf the medical users have the need for further clarification, they are asked to contact their local Brainlab Customer Support Representative. \n\nCustomer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by\nE-mail: support@brainlab.com. Fax Brainlab AG: + 49 89 99 15 68 33 \n\nAddress: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany.", "product_quantity": "2528 units / 2119 consignees", "distribution_pattern": "Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.", "openfda": { "k_number": [ 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