O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
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.
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https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2020