FDA-Device2026-06-24Class IIPROCESSING DEFECT
Medtronic O-arm O2 Imaging System recalled for potential image artifacts from firmware anomaly
OTHERNationwide distribution
Medtronic O-arm O2 recalled for image artifact risk
Medtronic has identified a firmware anomaly in the O-arm O2 Imaging System detector panel that can cause image artifacts during surgical imaging. The issue affects specific serial numbers of the O-arm O2 model BI70002000. No injuries have been reported.
- Check if your O-arm O2 system matches one of the affected serial numbers listed in the FDA notice
- Contact Medtronic if your system is affected to obtain a firmware update
- Review images from affected units for quality before relying on them for surgical guidance
Hazard
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Sold states
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.
Affected count
589 units
Manufactured in
200 Beaver Brook Road, Boxborough, MA, United States
Products
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2451-2026Don't want to check this manually?
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