Medtronic O2 Imaging System Recall: Damaged Support Component Risk
Medtronic recalls O-arm O2 Imaging Systems with damaged support components that could cause mechanical failure during use. Affected units have specific serial numbers and were sold with certain model identifiers.
Use caution until it’s fixed
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Contact the company
What happened, in plain English
Medtronic is recalling O-arm O2 Imaging Systems that may have a damaged support component from manufacturing. This could lead to mechanical failure during use, potentially causing injury if the system becomes unstable. Read more at govinfonow.com/recall/52215-medtronic-o2-imaging-system-recall-damaged-support-component-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/52215-medtronic-o2-imaging-system-recall-damaged-support-component-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2101-2025
Cite this page
“Medtronic O2 Imaging System Recall: Damaged Support Component Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52215-medtronic-o2-imaging-system-recall-damaged-support-component-risk. Based on FDA recall #Z-2101-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2101-2025%22&limit=1).
Why it’s dangerous
A mechanical component supporting the O2 gantry to the system's structure may have been damaged during manufacturing. This could cause the gantry to become unstable or misaligned during use, potentially leading to mechanical failure.
Who’s affected
Healthcare professionals using the O2 Imaging System for mobile X-ray are most at risk. Affected units have specific serial numbers and model identifiers.
How to tell if you have this one
Check for serial numbers C4014, C4017, or C4019 on the device. The system is identified by the model CFN BI70002000 and UDI 00763000709631.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Device Serial Number
Look for serial numbers C4014, C4017, or C4019 on the device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution in the states of IN, MN, MS.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Indiana, Minnesota, Mississippi.
Recall timeline
FDA published this recall 50 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-2101-2025 (May 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2101-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.