Medtronic recalls O-arm O2 Imaging System mobile x-ray devices for potential image guidance failure during surgery, risking delays, extra imaging, or incomplete procedures. Affected units have specific serial numbers and product codes.
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
Medtronic is recalling its O-arm O2 Imaging System mobile x-ray devices because an electrical component might shut off intermittently. This could lead to surgery delays, extra imaging, or incomplete procedures without proper image guidance.
The system's electrical component may shut off unexpectedly during surgery. This can cause delays, require additional imaging, or result in surgery being completed without the necessary image guidance, potentially affecting patient outcomes.
Healthcare providers using the O-arm O2 Imaging System for surgeries on adults and children are most at risk. The recall affects specific units with listed serial numbers and product codes.
Check if your device has serial numbers starting with C3578, C3421, C3606, or other listed numbers. The product code BI70002000 or GTINs listed in the recall notice also identify affected units.
Review your device's serial numbers to see if they match the listed affected numbers (e.g., C3578, C3421).
The O-arm O2 Imaging System may have an electrical component that shuts off intermittently, which can cause surgical delays, extra imaging, or incomplete procedures without image guidance.
Check your device's serial numbers against the list provided in the recall notice to see if it's affected. If it is, contact Medtronic for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2026-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2026-2024 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
