Recall Z-2451-2026
- Recall number
- Z-2451-2026
- Event number
- 99041
- Firm
- Medtronic Navigation, Inc.-Boxborough
- Firm FEI
- 3004785967
- Product code
- OWB
- Status
- Open, Classified
- Initiated
- 2026-05-19
- Posted
- 2026-06-15
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K240465, K203535, K181767, K130893, K172700, K242731, K082243, K041932, K160279, K241572, K912448, K032046, K230871, K181830, K163715, K030544, K022069, K970734, K221516, K041931, K011311, K201743, K936180, K181804, K053279, K152785, K052412, K233748, K143225, K050489
Product#
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Reason for Recall#
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.