{ "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": "167816", "product_res_number": "Z-0552-2019", "event_date_initiated": "2018-09-26", "event_date_posted": "2018-12-29", "recall_status": "Terminated", "event_date_terminated": "2024-09-05", "res_event_number": "81214", "product_code": "HAW", "k_numbers": [ "K150216", "K153660" ], "product_description": "StealthStation Cranial and Synergy Cranial Depth Gauge:\n\nStealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.\n\nBiopsy Needle Kit (9733068) Note: This device is an accessory to your StealthStation System. . . The Biopsy Needle is a presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc.", "code_info": "Product Number/CFN Affected Software Versions 9733763 2.2.0, 2.2.5, 2.2.6, 2.2.7 Synergy Cranial 9735585 3.0.0, 3.0.1, 3.0.2, 3.1.0 StealthStation S7 Cranial  Kit CFN and UDI: CFN GTIN Description 9733763\t00613994408174\tSOFTWARE, 9733763, SYNERGY CRANIAL S7 9734068\t00613994546081\tSFTWR KIT 9734068 SYN CRANI S7 PLNG STN 9734068\t00643169038110\tSFTWR KIT 9734068 SYN CRANI S7 PLNG STN 9733937\t00613994467102\tSoftware Kit 9733937 Synergy Cranial S7 9733937\t00643169037946\tSoftware Kit 9733937 Synergy Cranial S7 9733928\t00613994467126\tUpgrade Prgm 9733928 Treon to S7 220V 9734261\t00613994792884\tUPGRD PRGM 9734261 StealthStation S7 9734261-G02\t00643169510531\tUPGRD PRGM 9734261 StealthStation S7 9734849\t00613994944986\tUPGD PRGM 9734849 S7 CPTL ENH PRGM 9735064\t00643169192140\tUPGRD PRGM 9735064 KAISER TREON TO S7 9735328\t00643169332645\tUPGRD PRGM 9735328 Stealth S7 Touch¿ 9735328-G02\t00643169510548\tUPGRD PRGM 9735328 Stealth S7 Touch 9733937-G02\t00643169353305\tSoftware Kit 9733937 Synergy Cranial S7 9733763-G03\t00643169503311\tSOFTWARE, 9733763, SYNERGY CRANIAL S7 9733937-G03\t00643169481275\tSOFTWARE KIT 9733937 SYNERGY CRANIAL S7 9733928-G02\t00643169502611\tUPGRADE PRGM 9733928 TREON TO S7 220V 9734261-G03\t00643169641167\tUPGRD PRGM 9734261 StealthStation S7 9734849-G02\t00643169513754\tUPGD PRGM 9734849 S7 CPTL ENH PRGM 9735064-G02\t00643169510579\tUPGRD PRGM 9735064 KAISER TREON TO S7 9735328-G03\t00643169641174\tUPGRD PRGM 9735328 Stealth S7 Touch 9735065-G04\t00643169490475\tUPGRADE KIT 9735065 KAISER S7 9735070-G04\t00643169490482\tUPGRADE KIT 9735070 CRANIAL AXIEM S7 9733937-G04\t00643169505759\tSW KIT 9733937 SYNERGY CRANIAL S7 EU-NW 9733937-G05\t00643169505797\tSW KIT 9733937 SYNERGY CRANIAL S7 EU-SW 9733937-G06\t00643169505766\tSW KIT 9733937 SYNERGY CRANIAL S7 SCAND 9733937-G07\t00643169505773\tSW KIT 9733937 SYNERGY CRANIAL S7 EU-E 9733937-G08\t00643169505780\tSW KIT 9733937 SYNERGY CRANIAL S7 EU-SE 9734068-G02\t00643169481268\tSFTWR KIT 9734068 SYN CRANI S7 PLNG STN 9734068-G03\t00643169510562\tSW KIT 9734068 SYN CRAN S7 PLNG STN EUNW 9734068-G04\t00643169510586\tSW KIT 9734068 SYN CRAN S7 PLNG STN EUSW 9734068-G05\t00643169510593\tSWKIT 9734068 SYN CRAN S7 PLNG STN SCAND 9734068-G06\t00643169510609\tSW KIT 9734068 SYN CRAN S7 PLNG STN EU-E 9734068-G07\t00643169510616\tSW KIT 9734068 SYN CRAN S7 PLNG STN EUSE 9731975\t00885074238241\tTUMOR RESECTION PACK, 9731975, AxiEM CR 9733300\t00613994231031\tSHUNT PACK 9733300 AXIEM NON-INVASIVE 9735585\t00643169625532\tSOFTWARE 9735585 STEALTHSTATION CRANIAL 9735586\t00643169625570\tSW KIT 9735586 STEALTHSTATION CRANIAL 9735586\t00643169777101\tSW KIT 9735586 STEALTHSTATION CRANIAL 9735586-G02\t00643169625587\tSW KIT 9735586 STEALTH CRANIAL EU-NW 9735586-G03\t00643169625594\tSW KIT 9735586 STEALTH CRANIAL EU-SW 9735586-G04\t00643169625600\tSW KIT 9735586 STEALTH CRANIAL SCAND 9735586-G05\t00643169625617\tSW KIT 9735586 STEALTH CRANIAL EU-E 9735586-G06\t00643169625624\tSW KIT 9735586 STEALTH CRANIAL EU-SE 9735587\t00643169625631\tSW KIT 9735587 STEALTH CRANIAL PLNG STN 9735587-G02\t00643169625648\tSWKIT 9735587 STEALTH CRAN PLNG STN EUNW 9735587-G03\t00643169625655\tSWKIT 9735587 STEALTH CRAN PLNG STN EUSW 9735587-G04\t00643169625662\tSWKIT 9735587 STEALTH CRAN PLN STN SCAND 9735587-G05\t00643169625679\tSWKIT 9735587 STEALTH CRAN PLNG STN EU-E 9735587-G06\t00643169625686\tSWKIT 9735587 STEALTH CRAN PLNG STN EUSE 9735585-G02\t00763000095741\tSOFTWARE 9735585 STEALTHSTATION CRANIAL 9735586-G07\t00763000095758\tSW KIT 9735586 STEALTHSTATION CRANIAL 9735586-G08\t00763000095765\tSW KIT 9735586 STEALTH CRANIAL EU-NW 9735586-G09\t00763000095772\tSW KIT 9735586 STEALTH CRANIAL EU-SW 9735586-G10\t00763000095789\tSW KIT 9735586 STEALTH CRANIAL SCAND 9735586-G11\t00763000095796\tSW KIT 9735586 STEALTH CRANIAL EU-E 9735586-G12\t00763000095802\tSW KIT 9735586 STEALTH CRANIAL EU-SE 9735587-G07\t00763000095819\tSW KIT 9735587 STEALTH CRANIAL PLNG STN 9735587-G08\t00763000095826\tSWKIT 9735587 STEALTH CRAN PLNG STN EUNW 9735587-G09\t00763000095833\tSWKIT 9735587 STEALTH CRAN PLNG STN EUSW 9735587-G10\t00763000095840\tSWKIT 9735587 STEALTH CRAN PLN STN SCAND 9735587-G11\t00763000095857\tSWKIT 9735587 STEALTH CRAN PLNG STN EU-E 9735587-G12\t00763000095864\tSWKIT 9735587 STEALTH CRAN PLNG STN EUSE", "firm_fei_number": "1000517638", "recalling_firm": "Medtronic Navigation, Inc.", "address_1": "826 Coal Creek Cir", "city": "Louisville", "state": "CO", "postal_code": "80027-9710", "additional_info_contact": "Tom F. Reimann\n720-890-3241", "reason_for_recall": "An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.", "root_cause_description": "Device Design", "action": "On 09/26/2018, the firm sent an Urgent Medical Device Correction Notification to all US customers informing them of potential inaccuracy during biopsy procedures using the StealthStation S7 Depth Gauge feature on StealthStation S7 and i7 systems running Synergy Cranial and StealthStation Cranial software that could result in healthy tissue being biopsied. The notification letter stated, In navigated biopsy procedures, where the Navigate Projection feature is used and the projection is longer than the length of the plan, the graphical Biopsy Depth Gauge feature can display inaccurate information. The Biopsy Needle Depth Gauge is a numerical and graphical representation of the needle cutting window in the Guidance view quadrant to assist in visualization of the cutting window position.\n\nDuring a biopsy procedure, the monitor shows four quadrants (Trajectory 1, Trajectory 2, Guidance, and Probe s Eye views) as well as the Biopsy Depth Gauge. The overlay of the Biopsy Needle within the anatomical views accurately indicates the correct tip location of the instrument. However, if Navigate Projection is selected, and the projection is longer than the length of the plan, then the Biopsy Depth Gauge graphical display inaccurately depicts that the tip of the instrument has not yet reached the plan target. Since 2011, Medtronic has received seven (7) complaints potentially related to this software anomaly, one in which healthy tissue was biopsied.\n\nThe image on page two contains an example of the error use case. All views correctly show that the instrument is past the target, and the Depth Gauge correctly displays the past-target measurement of -63, which indicates the instrument tip has advanced 63 mm beyond the intended target. However, the graphical Biopsy Needle cut window appears not to have advanced to the target position.\n\nIf the surgical team relies solely on the graphical representation in the Biopsy Depth Gauge feature and disregards other factors (such as", "product_quantity": "5487 impacted systems", "distribution_pattern": "US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY\n\nOUS: Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherland, New Zealand, Nicaragua, Norway, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam", "openfda": { "k_number": [ "K151359", "K001431", "K050651", "K261932", "K030106", "K190250", "K191597", "K121950", "K935456", "K130608", "K051676", "K072806", "K200079", "K253379", "K230661", "K013396", "K172820", "K012380", "K250505", "K032054", "K231976", "K223864", "K874833", "K010602", "K001801", "K080547", "K153281", "K040368", "K233155", "K852477", "K190672", "K052966", "K983539", "K073467", "K915791", "K201752", "K003268", "K981508", "K881131", "K031770", "K080250", "K122096", "K003589", "K102130", "K003201", "K233703", "K063028", "K992304", "K160811", "K113228", 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