Quick Facts at a Glance
- Recall Date
- May 19, 2026
- Hazard Level
- HIGH
- Brand
- Medtronic Navigation, Inc.-Boxborough
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic Navigation, Inc.-Boxborough
- Model numbers
- Model Number: BI70002000. GTIN (Serial Numbers): 00643169639683 (C1640), 00643169651814 (C3815, C3816, C3817, C3818, C3891, C3898, C3899 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 19, 2026
Reported by FDA DEVICE
June 24, 2026
RecallRadar source check
June 30, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Navigation, Inc.-Boxborough or your healthcare provider for instructions. Notification method: Letter
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Full Description
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.. Reason: Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.. Classification: Class II. Quantity: 589 units. 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.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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