Medtronic recalls specific O-arm O2 Imaging Systems due to a potential gantry belt loosening that could cause 3D images to rotate relative to patient position. Affected units have unique serial numbers and product codes.
Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.
Medtronic is recalling certain O-arm O2 Imaging Systems because a manufacturing issue may cause the gantry belt to loosen over time. This could lead to 3D images rotating relative to the patient's actual position, potentially causing misaligned treatment planning. The recall affects specific units with known serial numbers.
The gantry tractor motor drive belt may loosen over time in these systems. If it loosens, the 3D images could rotate around the gantry isocenter, meaning the electronic registration of the images might not match the patient's physical position. This could lead to misaligned treatment planning if the images are used for therapy confirmation.
Patients using the recalled O-arm O2 Imaging Systems for medical procedures are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your O-arm O2 Imaging System has the product number BI-700-02000 and serial numbers starting with C2155 through C2266. The recall includes specific serial numbers listed in the official notice.
Verify if your device has a serial number from the list provided in the recall notice.
Medtronic identified a manufacturing issue that could cause the gantry tractor motor drive belt to loosen over time in specific O-arm O2 Imaging Systems.
If the belt loosens, the 3D images may rotate relative to the patient's actual position, potentially causing misaligned treatment planning.
Check if your device has the product number BI-700-02000 and a serial number from the list of C2155 through C2266 provided in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0767-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0767-2020 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.
