Medtronic Navigation, Inc.-boxborough: Medtronic O-arm O2 Imaging System. Model Number: Bi70002000
Recall Summary Medtronic is recalling the O-arm O2 Imaging System (Model BI70002000) worldwide due to a firmware problem in the detector panel that can cause image artifacts during use. The system is used for surgical imaging and the defect may affect image quality. The recall affects devices distributed across the United States and 50+ countries internationally.
- Recalling firm
- Medtronic Navigation, Inc.-Boxborough
- Product
- Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
- Reason
- Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-19
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/d6e52b92-d9d5-456f-aaef-808551851ebc