Z-1630-2023 Class I Ongoing
FDA device recall Z-1630-2023 was initiated by Medtronic Navigation, Inc. on April 11, 2023 and is designated Class I. Reason for recall: During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigation… The recall status is ongoing. Affected quantity: 746.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- April 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 746
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY. OUS (foreign): ALBANIA, ARGENTINA, Australia, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, Bosnia and Herzegovina, BULGARIA, CANADA, CHILE, CROATIA, CZECH REPUBLIC, DENMARK, FRANCE, GREECE, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MARTINIQUE, NEW ZEALAND, POLAND, PORTUGAL, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, Turkey, UNITED ARAB EMIRATES, UNITED KINGDOM