Recall Z-2451-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Medtronic Navigation, Inc.-Boxborough
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
| Date | Jun 15, 2026 (initiated May 19, 2026) |
| Status | Open, Classified |
| Reason | Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. |
| Root cause | Under Investigation by firm |
| Action | 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 For |
| Quantity | 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 Republic, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Ir |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240465 | O-arm O2 Imaging System Medtronic Navigation, Inc., Jun 21, 2024 |