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Recall

Medtronic Navigation, Inc.-Boxborough: Medtronic O-arm O2 Imaging System. Model Number: BI70002000. Recall

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. Product details: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

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Agency
FDA
Record ID
Z-2451-2026
Canonical
https://claimwatch-mvp.vercel.app/item/medtronic-navigation-inc-boxborough-medtronic-o-arm-o2-imaging-system-model-number-bi70002/

What happened?

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. Product details: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Who may be affected?

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.

What should consumers do?

Affected quantity: 589 units

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