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
Get free recall alerts
New Medical Devices recalls, the moment they post.
Free forever. Unsubscribe anytime. We never sell your data.
More Medical Devices recalls
Boston Scientific Rapid Refill Injection System Recall
Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the manifold. This can …
Boston Scientific Corporation
FARASTAR Ablation Generator Recall
Boston Scientific is replacing certain FARASTAR Pulsed Field Ablation generators that cannot work with the FARAPOINT catheter. If your generator has an …
Boston Scientific Corporation
Faradive Steerable Sheath Clear Recall
The Faradive Steerable Sheath Clear used in cardiac catheterization procedures may allow air to enter the bloodstream if the dilator is inserted incorrectly …
Boston Scientific Corporation