Medtronic O-arm O2 Imaging System
Medtronic is recalling the O-arm O2 Imaging System due to a firmware anomaly that may cause image artifacts during clinical use.
Contact your local Medtronic representative or the company's technical support team to schedule a firmware update for your device.
Recall at a glance
- Quantity recalled
- 589 units
Why it was recalled
Medtronic is recalling the O-arm O2 Imaging System due to a firmware anomaly in the detector panel that may cause image artifacts. These artifacts could potentially lead to inaccurate surgical navigation or clinical assessment.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Medtronic O-arm O2 Imaging System.
- Model
- BI70002000
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Software Defect recalls
Editorial summary by Recall Canary · summary updated 2026-06-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification