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Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Class II
Recalling firm
Medtronic Navigation, Inc.-Boxborough
Reason for recall
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Distribution pattern
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.
State
MA
Status
Ongoing
Recall number
Z-2451-2026
Recall initiated
May 19, 2026
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