Official recall notice
FDA DeviceClass IINotable
FDA Recall: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
- Recall date
- 2026-06-24
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Recommended action
What to do
589 units
Product description
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.