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.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
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.
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.
Healthcare professionals using the O2 Imaging System for mobile X-ray are most at risk. Affected units have specific serial numbers and model identifiers.
Check for serial numbers C4014, C4017, or C4019 on the device. The system is identified by the model CFN BI70002000 and UDI 00763000709631.
Look for serial numbers C4014, C4017, or C4019 on the device.
A mechanical component supporting the O2 gantry to the system's structure may have been damaged during manufacturing.
Check for serial numbers C4014, C4017, or C4019 on the device. The system is identified by the model CFN BI70002000 and UDI 00763000709631.
The recall record does not specify a remedy, so no action is required beyond checking if your device has the affected serial numbers.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2101-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2101-2025 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.
