{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198099", "product_res_number": "Z-1135-2023", "event_date_initiated": "2023-01-16", "event_date_posted": "2023-02-13", "recall_status": "Open, Classified", "res_event_number": "91518", "product_code": "KPS", "k_numbers": [ "K193248" ], "product_description": "SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile", "code_info": "a) Flow 64-4R Seismic, UDI/DI 405686900142560047, Material Number 10529161, Serial Number 60047; \nb) S(40)-3R Seismic, UDI/DI 405686900131960054, Material Number 10248668, Serial Number 60054; \nc) S(64)-3R Seismic, UDI/DI 405686900133360091, Material Number 10248669, Serial Number 60091; \nd) S(40)-4R Seismic, UDI/DI 405686900132660047, Material Number 10248671, Serial Number 60047; \ne) S(64)-4R Seismic, UDI/DI 405686900134060076, Material Number 10248672, Serial Number 60076; \nf) S(20)-3R Mobile, UDI/DI 405686900129660028\n\n Material Number 10534159, Serial Number 60028", "firm_fei_number": "1000514697", "recalling_firm": "Siemens Medical Solutions USA, Inc.", "address_1": "2501 Barrington Rd", "city": "Hoffman Estates", "state": "IL", "postal_code": "60192-2061", "additional_info_contact": "Siemens Healthineers Representative\n800-888-7436", "reason_for_recall": "This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.", "root_cause_description": "Process control", "action": "SIEMENS Healthineers distributed a Consumer Safety Advisory Notice to its consignees on 01/16/2023 by mail and email. The notice explained the issue and recommended that the following preventive actions be taken until a local Siemens Healthineers service representative has applied the correction: \n\"Mitigation for Biograph Mobile Installations\n Ensure that the PET/CT Gantry offset protocol is performed every time the coach has moved. If the PET/CT gantry offset fails due to the results being out of tolerance, please cease clinical operations on the system and contact your local Siemens Healthineers service representative for further evaluation and guidance on how to proceed. Information on how to acquire the PET/CT Gantry offset protocol is documented in your user documentation.\nMitigation for Biograph Seismic Installations\n In the event of a seismic event, contact your local Siemens Healthineers service representative for further evaluation and guidance on how to proceed.\nSiemens Healthineers will begin dispatching customer service engineers by the end of February 2023 to inspect and make corrections to the locking mechanism to prevent the occurrence of this issue. The resolution for this issue will be delivered by the following Update Instruction: MI516/22/S.\nPlease ensure that this notice is placed in the Biograph Operator Manual and disseminated to all operators of the scanner.\"\n\n\"If you have any questions regarding this advisory notice, please contact your local Siemens Healthineers representative at the contact numbers provided below.\n America: 1-800-888-7436\n Europe, Middle East, and Africa: +49 9131 940 4000\n Asia and Australia: +86 (21) 3811 2121\"", "product_quantity": "6 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.", "openfda": { "k_number": [ "K060631", "K173578", "K942146", "K896458", "K963162", "K960192", "K241751", "K233677", "K090178", "K982387", "K934722", "K964712", "K850416", "K960865", "K981352", "K210173", "K050559", "K942116", "K173547", "K963983", "K023768", "K021656", "K181343", "K181468", "K193152", "K123737", "K030199", "K043441", "K231102", "K161740", "K042863", "K941223", "K981553", "K912176", "K931297", "K013667", "K972686", "K170490", "K003241", "K212604", "K182938", "K051170", "K202882", "K223325", "K042467", "K991129", "K030085", "K232712", "K223422", "K180077", "K970128", "K982044", "K143664", "K071068", "K914527", "K023110", "K912177", "K072307", "K963273", "K942860", "K230600", "K243881", "K121019", "K945652", "K123599", "K802801", "K041182", "K781753", "K130269", "K001681", "K231833", "K222895", "K240827", "K231748", "K914807", "K041220", "K003434", "K981027", "K884349", "K090403", "K970970", "K922373", "K081453", "K211846", "K964267", "K162736", "K964266", "K791055", "K931193", "K890100", "K021823", "K940236", "K014033", "K042257", "K214062", "K172609", "K964834", "K913637", "K033735", "K251401", "K965226", "K241266", "K042880", "K081135", "K010137", "K091269", "K023932", "K051351", "K180318", "K241364", "K013353", "K251671", "K952674", "K810589", "K002715", "K920776", "K033782", "K953801", "K171303", "K040933", "K913641", "K251561", "K980867", "K936001", "K894998", "K243186", "K082244", "K003849", "K162337", "K141652", "K933372", "K954874", "K193210", "K032500", "K960948", "K980715", "K041166", "K994167", "K981291", "K051460", "K193248", "K223547", "K933446", "K172143", "K022240", "K982911", "K161631", "K100714", "K963730", "K231731", "K971878", "K982171", "K022001", "K053086", "K022872", "K140651", "K033431", "K011572", "K923345", "K161674", "K083649", "K033001", "K253844", "K002229", "K180811", "K253564", "K901019", "K961597", "K191582", "K952109", "K951144", "K992731", "K790169", "K032036", "K081201", "K083504", "K041218", "K081496", "K053062", "K153402", "K061587", "K080784", "K954143", "K103710", "K142006", "K942837", "K002584", "K081426", "K003264", "K082581", "K964265", "K926206", "K933321", "K982045", "K042903", "K223212", "K051855", "K261315", "K151403", "K030870", "K172406", "K203314", "K090553", "K932745", "K032779", "K962955", "K974444", "K001888", "K201933", "K983514", "K241898", "K221932", "K113408", "K182237", "K080124", "K042935", "K211247", "K892875", "K043381", "K964438", "K925186", "K202392", "K993893", "K250170", "K211764", "K051549", "K992317", "K130902", "K182336", "K112474", "K210418", "K202349", "K252477", "K243538", "K953255", "K982300", "K954129", "K991535", "K983948", "K913630", "K012775", "K121278", "K894056", "K050815", "K953193", "K113086", "K992335", "K972509", "K001026", "K101550", "K942145", "K192277", "K946334", "K892358", "K033254", "K041543", "K940478", "K210001", "K962797", "K101013", "K171719", "K210557", "K992450", "K113448", "K173023", "K033199", "K152880", "K111445", "K113754", "K152503", "K992992", "K231762", "K930428", "K010509", "K062298", "K042839", "K011611", "K160120", "K201807", "K973396", "K911275", "K163394", "K964012", "K770220", "K013496", "K173816", "K180514", "K082368", "K091073", "K980959", "K992078", "K920624", "K020300", "K261427", "K041671", "K992560", "K873775", "K153056", "K141971", "K973233", "K031872", "K141074", "K031874", "K040172", "K040616", "K915644", "K211964", "K193178", "K875378", "K952684", "K021633", "K923044", "K955484", "K862511", "K922080", "K962100", "K974256", "K912573", "K251153", "K243605", "K923309", "K073021", "K071503", "K162483", "K961577", "K914179", "K031825", "K913471", "K131634", "K232569", "K062393", "K212004", "K896151", "K033874", "K241596", "K080575", "K935318", "K072567", "K231572", "K080927", "K060060", "K241585", "K843366", "K022960", "K952564", "K970627", "K202679", "K090811", "K113350", "K193241", "K060486", "K971980", "K942363", "K983516", "K041840", "K970288", "K914267", "K131625", "K943596", "K921777", "K070589", "K924498", "K023518", "K061545", "K083852", "K991841", "K231576", "K922671", "K940487", "K041022", "K141477", "K043293", "K033956", "K200474", "K101768", "K132347", "K944720", "K023988", "K110507", "K093514", "K082904", "K142631", "K922427", "K260524", "K123433", "K012568", "K911078", "K922303", "K052434", "K926133", "K032063", "K133657", "K962738", "K922313", "K251839", "K072191", "K001276", "K041955", "K963406", "K980914", "K922426", "K070542", "K130451", "K082506", "K042428", "K940300", "K920958", "K131233", "K210880", "K170904", "K013504", "K911290", "K991896", "K972360", "K210262", "K040141", "K925330", "K082354", "K062450", "K002553", "K123646", "K151486", "K140206", "K072468", "K945721", "K991318", "K190457", "K241665", "K914296", "K861252", "K952190", "K050366", "K003882", "K140269", "K140996", "K003358", "K060020", "K251370", "K042258", "K921008", "K982855", "K945261", "K032866", "K964268", "K922372", "K040057", "K923151", "K254001", "K923736", "K924877", "K182484", "K161574", "K000908", "K900892", "K852239", "K190900", "K991607", "K991565", "K040370", "K910048", "K915470", "K213731", "K052640", "K052430", "K891266", "K210450", "K122241", "K040326", "K962481", "K031705", "K171681", "K050509" ], "registration_number": [ "3016007746", "8030233", "3015276088", "3012085143", "3015763655", "3015232217", "3011015597", "3011950073", "3008355361", "1833124", "3027338963", "1066019", "2411512", "3014954414", "3007545404", "3014134519", "3004993756", "3006611212", "2126677", "8022257", "3010703925", "2031050", "1423253", "3005810333", "3003477135", "1034973", "3005945241", "3007675950", "3014343100", "2247992", "3010398867", "1423348", "3035950510", "3012690638", "1424263", "3030186509", "1450662", "3023003446", "3030210400", "3013679558", "3008007310", "3026391023", "3027339477", "3009136051", "3008632256", "3034246184", "3033524251", "3014470527", "3002808157", "3011416394", "9611343", "3014809646", "3021032044", "3032577207", "9613299", "3036666444", "9613445", "3009963139", "3000976525", "3005877899", "3009196578", "3012761544", "9710645", "3018788582", "2320968", "9613936", "3008496839", "3015777306", "3000126629", "3006209933", "3022742930", "3004504920", "3026047529", "3005128583", "9617978", "3029521953", "3030982377", "3008962177", "9614698", "3031503890", "3004754211", "3015425142", "3017375271", "3021059265", "2134213" ], "fei_number": [ "3016007746", "3002808139", "3015276088", "3012085143", "3015763655", "3015232217", "3011015597", "3011950073", "3004571294", "3003079232", "3008355361", "3008581796", "1833124", "3027338963", "2411512", "3014954414", "3007545404", "3014134519", "3002175190", "3003318268", "3002808382", "3004993756", "3001654007", "3006611212", "2126677", "3003015552", "3010703925", "3005810333", "3003477135", "1034973", "3005945241", "3007675950", "3014343100", "3010398867", "1000208827", "3035950510", "3012690638", "3030186509", "1450662", "3023003446", "3030210400", "3013679558", "3008007310", "3026391023", "1000284313", "3027339477", "3009136051", "3008632256", "3034246184", "3033524251", "3014470527", "3002808157", "3011416394", "3014809646", "3001236767", "1000571342", "3021032044", "1000514697", "3032577207", "3003757840", "3036666444", "3009963139", "3000976525", "3005877899", "3009196578", "3012761544", "3018788582", "3008496839", "3015777306", "3000126629", "3006209933", "3022742930", "3004504920", "3026047529", "3005128583", "3029521953", "3030982377", "3000210013", "3008962177", "3031503890", "3004754211", "3015425142", "3002831423", "3017375271", "3021059265" ], "device_name": "System, Tomography, Computed, Emission", "medical_specialty_description": "Radiology", "regulation_number": "892.1200", "device_class": "2" } } ] }