Medtronic Navigation, Inc.-boxborough: Interventional Fluoroscopic X-ray System
Medtronic is recalling the O-arm O2 Imaging System (Model BI70002000) used in interventional fluoroscopic X-ray procedures because a firmware problem in the detector panel can cause image artifacts. The recall affects devices distributed worldwide, including throughout the United States and numerous other countries. This is a Class II recall, indicating a potential health hazard but not an immediate threat to life.
- 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
- FDA-DEVICES
- Recall date
- 2026-05-19
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4ee6e30c-9c96-4267-9d13-8d25f2a71745