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Medtronic Navigation, Inc.-Littleton recalls O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Recalled January 8, 2020 · FDA recall Z-0767-2020 · Medtronic Navigation, Inc.-Littleton
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. · FDA Class II
Units
90
Sold at
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Description
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.
Product
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Manufacturer(s)
Medtronic Navigation, Inc.-Littleton
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →