{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Louisville",
      "state": "CO",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81214",
      "recalling_firm": "Medtronic Navigation, Inc.",
      "address_1": "826 Coal Creek Cir",
      "address_2": "N/A",
      "postal_code": "80027-9710",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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    OUS: 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",
      "recall_number": "Z-0552-2019",
      "product_description": "StealthStation Cranial and Synergy Cranial Depth Gauge:    StealthStation 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.    Biopsy 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.",
      "product_quantity": "5487 impacted systems",
      "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.",
      "recall_initiation_date": "20180926",
      "center_classification_date": "20181229",
      "termination_date": "20240905",
      "report_date": "20190109",
      "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 00613994408174 SOFTWARE, 9733763, SYNERGY CRANIAL S7  9734068 00613994546081 SFTWR KIT 9734068 SYN CRANI S7 PLNG STN  9734068 00643169038110 SFTWR KIT 9734068 SYN CRANI S7 PLNG STN  9733937 00613994467102 Software Kit 9733937 Synergy Cranial S7  9733937 00643169037946 Software Kit 9733937 Synergy Cranial S7  9733928 00613994467126 Upgrade Prgm 9733928 Treon to S7 220V  9734261 00613994792884 UPGRD PRGM 9734261 StealthStation S7  9734261-G02 00643169510531 UPGRD PRGM 9734261 StealthStation S7  9734849 00613994944986 UPGD PRGM 9734849 S7 CPTL ENH PRGM  9735064 00643169192140 UPGRD PRGM 9735064 KAISER TREON TO S7  9735328 00643169332645 UPGRD PRGM 9735328 Stealth S7 Touch¿  9735328-G02 00643169510548 UPGRD PRGM 9735328 Stealth S7 Touch  9733937-G02 00643169353305 Software Kit 9733937 Synergy Cranial S7  9733763-G03 00643169503311 SOFTWARE, 9733763, SYNERGY CRANIAL S7  9733937-G03 00643169481275 SOFTWARE KIT 9733937 SYNERGY CRANIAL S7  9733928-G02 00643169502611 UPGRADE PRGM 9733928 TREON TO S7 220V  9734261-G03 00643169641167 UPGRD PRGM 9734261 StealthStation S7  9734849-G02 00643169513754 UPGD PRGM 9734849 S7 CPTL ENH PRGM  9735064-G02 00643169510579 UPGRD PRGM 9735064 KAISER TREON TO S7  9735328-G03 00643169641174 UPGRD PRGM 9735328 Stealth S7 Touch  9735065-G04 00643169490475 UPGRADE KIT 9735065 KAISER S7  9735070-G04 00643169490482 UPGRADE KIT 9735070 CRANIAL AXIEM S7  9733937-G04 00643169505759 SW KIT 9733937 SYNERGY CRANIAL S7 EU-NW  9733937-G05 00643169505797 SW KIT 9733937 SYNERGY CRANIAL S7 EU-SW  9733937-G06 00643169505766 SW KIT 9733937 SYNERGY CRANIAL S7 SCAND  9733937-G07 00643169505773 SW KIT 9733937 SYNERGY CRANIAL S7 EU-E  9733937-G08 00643169505780 SW KIT 9733937 SYNERGY CRANIAL S7 EU-SE  9734068-G02 00643169481268 SFTWR KIT 9734068 SYN CRANI S7 PLNG STN  9734068-G03 00643169510562 SW KIT 9734068 SYN CRAN S7 PLNG STN EUNW  9734068-G04 00643169510586 SW KIT 9734068 SYN CRAN S7 PLNG STN EUSW  9734068-G05 00643169510593 SWKIT 9734068 SYN CRAN S7 PLNG STN SCAND  9734068-G06 00643169510609 SW KIT 9734068 SYN CRAN S7 PLNG STN EU-E  9734068-G07 00643169510616 SW KIT 9734068 SYN CRAN S7 PLNG STN EUSE  9731975 00885074238241 TUMOR RESECTION PACK, 9731975, AxiEM CR  9733300 00613994231031 SHUNT PACK 9733300 AXIEM NON-INVASIVE  9735585 00643169625532 SOFTWARE 9735585 STEALTHSTATION CRANIAL  9735586 00643169625570 SW KIT 9735586 STEALTHSTATION CRANIAL  9735586 00643169777101 SW KIT 9735586 STEALTHSTATION CRANIAL  9735586-G02 00643169625587 SW KIT 9735586 STEALTH CRANIAL EU-NW  9735586-G03 00643169625594 SW KIT 9735586 STEALTH CRANIAL EU-SW  9735586-G04 00643169625600 SW KIT 9735586 STEALTH CRANIAL SCAND  9735586-G05 00643169625617 SW KIT 9735586 STEALTH CRANIAL EU-E  9735586-G06 00643169625624 SW KIT 9735586 STEALTH CRANIAL EU-SE  9735587 00643169625631 SW KIT 9735587 STEALTH CRANIAL PLNG STN  9735587-G02 00643169625648 SWKIT 9735587 STEALTH CRAN PLNG STN EUNW  9735587-G03 00643169625655 SWKIT 9735587 STEALTH CRAN PLNG STN EUSW  9735587-G04 00643169625662 SWKIT 9735587 STEALTH CRAN PLN STN SCAND  9735587-G05 00643169625679 SWKIT 9735587 STEALTH CRAN PLNG STN EU-E  9735587-G06 00643169625686 SWKIT 9735587 STEALTH CRAN PLNG STN EUSE  9735585-G02 00763000095741 SOFTWARE 9735585 STEALTHSTATION CRANIAL  9735586-G07 00763000095758 SW KIT 9735586 STEALTHSTATION CRANIAL  9735586-G08 00763000095765 SW KIT 9735586 STEALTH CRANIAL EU-NW  9735586-G09 00763000095772 SW KIT 9735586 STEALTH CRANIAL EU-SW  9735586-G10 00763000095789 SW KIT 9735586 STEALTH CRANIAL SCAND  9735586-G11 00763000095796 SW KIT 9735586 STEALTH CRANIAL EU-E  9735586-G12 00763000095802 SW KIT 9735586 STEALTH CRANIAL EU-SE  9735587-G07 00763000095819 SW KIT 9735587 STEALTH CRANIAL PLNG STN  9735587-G08 00763000095826 SWKIT 9735587 STEALTH CRAN PLNG STN EUNW  9735587-G09 00763000095833 SWKIT 9735587 STEALTH CRAN PLNG STN EUSW  9735587-G10 00763000095840 SWKIT 9735587 STEALTH CRAN PLN STN SCAND  9735587-G11 00763000095857 SWKIT 9735587 STEALTH CRAN PLNG STN EU-E  9735587-G12 00763000095864 SWKIT 9735587 STEALTH CRAN PLNG STN EUSE"
    }
  ]
}