Z-0383-2022 Class I Ongoing
FDA device recall Z-0383-2022 was initiated by Medtronic Navigation, Inc. on November 11, 2021 and is designated Class I. Reason for recall: Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect posi… The recall status is ongoing. Affected quantity: 2587.
Recall Details
- Product Type
- Devices
- Report Date
- December 29, 2021
- Initiation Date
- November 11, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2587
Product Description
Reason for Recall
Distribution Pattern
US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL, MS, MO, TX, MI, MT, OH, NY, VA, MA, CT, TN, WV, WA, NC, CO, NV, ME, LA, DE, NM, IN, UT, DC, OR, SC, OK, IA, HI, ID, KS, WY, MN, PR OUS: AU, BN, GU, JP, KR, MY, NZ, SG, TH, VN, MM, CA, CZ, RU, AL, CY, DE, ES, FR, GB, HU, IL, IT, NL, PL, RO, CN, HK, TW, IN, LK, NP, AR, BB, BR, CL, CO, CR, DO, EC, MX, PE, PR, VE, NI, UY, AE, BH, DZ, EG, IQ, JO, KZ, KE, SA, LB, LY, MA, NA, PK, QA, ZA, TR, AT, BE, CH, DK, FI, GF, GR, IE, LV, LT, LU, PT, SE, SK, UK, BA, BG, CI, HR, RS, SI