Medical Device Recall: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Medtronic Navigation, Inc.-Boxborough · May 19, 2026
Reason for Recall
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
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, 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.
States Affected
NATIONWIDE
Quantity Affected
589 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2451-2026
Status: ongoing
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