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Medtronic Navigation, Inc.-Boxborough recalls Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Recalled June 24, 2026 · FDA recall Z-2451-2026 · Medtronic Navigation, Inc.-Boxborough
Hazard
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. · FDA Class II
Units
589 units
Sold at
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, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Libya, Malaysia, Mexico, Morocco, Nepal, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Description
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Product
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Manufacturer(s)
Medtronic Navigation, Inc.-Boxborough
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →