FDANovember 15, 2019device

O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

medtronic navigation inc littletonmedtronicmedtronic navigation

UPCs

007630000741040076300013237800763000074128007630001344880076300008100300763000074067007630001686050076300007413500763000134518007630000810410076300013582900763000081102

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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