Reported Jan 8, 2020 · Terminated
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Medtronic Navigation, Inc.-Littleton
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc.-Littleton · 300 Foster St · Littleton, MA · 01460-2017
Is this the product you have?
- O-arm" O2 Imaging System
- Product Number/CFNBI-700-02000
- Lot codes and dates
- SN
87 of 87 codes
C2155C2180C2193C2203C2213C2223C2233C2243C2257C2267C2157C2181C2194C2204C2214C2224C2234C2247C2258C2268C2165C2182C2195C2205C2215C2225C2235C2248C2259C2166C2183C2196C2206C2216C2226C2236C2250C2260C2167C2185C2197C2207C2217C2227C2237C2251C2261C2169C2186C2198C2208C2218C2228C2238C2252C2262C2172C2187C2199C2209
- C2222 C2232 C2242 C2256 C2266 UDIs
00763000074104007630001323780076300007412800763000134488 0076300008100300763000074067007630001686050076300007413500763000134518007630000810410076300013582900763000081102007630000740500076300007409800763000135836
- SN
- Amount recalled
- 90
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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