Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
FDA device recall Z-2451-2026 · posted 2026-06-15 · Open, Classified
Recall details
- Recalling firm
- Medtronic Navigation, Inc.-Boxborough
- Reason for recall
- Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
- Action taken
- Medtronic notified consignees on about 05/19/2026 via "URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION" letter. Consignees were informed that affected systems may continue to be used prior to service by Medtronic to update the firmware. The issue is intermittent and may not present, however if it does it can be resolved by power cycling (rebooting) the system. A Medtronic Field Service Engineer will contact each facility to schedule time to update the firmware on each system to permanently resolve this issue. Consignees were instructed to complete and return the provided Customer Confirmation Form, provide the notification to all applicable personnel within the organization or to customers if product has been transferred, and to maintain a copy of the notice with their records.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 589 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech Repu
- Date initiated
- 2026-05-19
- Date posted
- 2026-06-15
- Location
- Boxborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-arm O2 Imaging System (K240465) | Medtronic Navigation, Inc. | 2024-06-21 |