Medtronic O-arm O2 Imaging System Recall
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Updated May 19, 2026
The Medtronic O-arm O2 Imaging System (Model BI70002000) can produce distorted or incorrect images due to a firmware defect in its detector panel. This imaging error could affect diagnostic accuracy during medical procedures.
Is the Medtronic Navigation, Inc.-Boxborough recalled? Yes. This product was recalled by FDA on May 19, 2026. Details below.
What is recalled
Medtronic O-arm O2 Imaging System, Model Number BI70002000.
Am I affected
You are affected if your facility uses a Medtronic O-arm O2 Imaging System with Model Number BI70002000.
What to do right now
Contact Medtronic to request a firmware update or instructions for your system. Check with your facility's engineering or biomedical team for next steps.
The hazard
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2451-2026
- Classification
- Class II
- Recalled
- May 19, 2026
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