Medtronic O-arm O2 Imaging System Model BI70002000: Potential Image Artifacts
Medtronic recalls O-arm O2 Imaging System model BI70002000 due to potential image artifacts from a detector panel firmware anomaly. Affected units have specific serial numbers listed in the recall notice.
Lower-risk recall
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Contact the company
What happened, in plain English
Medtronic is recalling its O-arm O2 Imaging System model BI70002000 because a firmware issue in the detector panel can cause image artifacts. This affects medical imaging equipment used in hospitals and clinics. Read more at govinfonow.com/recall/49147-medtronic-o-arm-o2-imaging-system-model-bi70002000-potential-image.
Source Summary by GovInfoNow · govinfonow.com/recall/49147-medtronic-o-arm-o2-imaging-system-model-bi70002000-potential-image · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2451-2026
Cite this page
“Medtronic O-arm O2 Imaging System Model BI70002000: Potential Image Artifacts.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49147-medtronic-o-arm-o2-imaging-system-model-bi70002000-potential-image. Based on FDA recall #Z-2451-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2451-2026%22&limit=1).
Why it’s dangerous
The detector panel firmware has an anomaly that can cause image artifacts during medical imaging procedures. This may lead to inaccurate images but does not pose a direct safety risk to users.
Who’s affected
Healthcare facilities using the O-arm O2 Imaging System model BI70002000 are most at risk. The recall targets specific units with listed serial numbers.
How to tell if you have this one
Check if your O-arm O2 Imaging System has model number BI70002000 and the specific serial numbers listed in the recall notice. The serial numbers are provided in the GTIN (product code) section.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Product Details
Verify your O-arm O2 Imaging System model number and serial numbers against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2451-2026 (May 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2451-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.