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Open, Classified

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

FDA Recall Z-2451-2026 · Posted 2026-06-15

Recalling FirmMedtronic Navigation, Inc.-Boxborough
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-05-19
Product Quantity589 units

Reason for Recall

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

Firm Action

Medtronic notified consignees on about 05/19/2026 via "URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION" letter. Consignees were informed that affected systems may continue to be used prior to service by Medtronic to update the firmware. The issue is intermittent and may not present, however if it does it can be resolved by power cycling (rebooting) the system. A Medtronic Field Service Engineer will contact each facility to schedule time to update the firmware on each system to permanently resolve this issue. Consignees were instructed to complete and return the provided Customer Confirmation Form, provide the notification to all applicable personnel within the organization or to customers if product has been transferred, and to maintain a copy of the notice with their records.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K240465O-arm O2 Imaging SystemMedtronic Navigation, Inc. · 2024-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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