O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Check against the official notice below — it lists the full affected range.
Medtronic is recalling certain O-arm O2 Imaging Systems due to a manufacturing issue that may cause the gantry tractor motor drive belt to loosen after extended use. When the belt loosens, it can cause 3D images to rotate around the gantry isocenter, meaning the electronic registered location of the 3D image may not align with the patient's actual physical position, even though the image itself remains anatomically accurate. This misalignment could affect the accuracy of therapy guidance based on the imaging system's electronic registration.
The recall affects 90 units distributed across multiple U.S. states and international locations including Australia, Canada, China, France, Germany, India, Italy, Japan, and others. Affected units can be identified by their serial numbers (ranging from C2155 to C2266) or specific Universal Device Identifiers (UDIs) listed in the recall documentation. The source document does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US: AR CA CO CT FL ID IL IN KS KY MI MN MO NC ND NE NY OH OR PA SC SD TX VA WA WI WV OUS: AUSTRALIA CANADA CHINA FRANCE GERMANY INDIA ITALY JAPAN LEBANON NETHERLANDS ROMANIA SAUDI ARABIA SPAIN SWEDEN SWITZERLAND UNITED KINGDOM Quantity: 90 Lot/code info: SN: C2155 C2180 C2193 C2203 C2213 C2223 C2233 C2243 C2257 C2267 C2157 C2181 C2194 C2204 C2214 C2224 C2234 C2247 C2258 C2268 C2165 C2182 C2195 C2205 C2215 C2225 C2235 C2248 C2259 C2166 C2183 C2196 C2206 C2216 C2226 C2236 C2250 C2260 C2167 C2185 C2197 C2207 C2217 C2227 C2237 C2251 C2261 C2169 C2186 C2198 C2208 C2218 C2228 C2238 C2252 C2262 C2172 C2187 C2199 C2209 C2219 C2229 C2239 C2253 C2263 C2176 C2189 C2200 C2210 C2220 C2230 C2240 C2254 C2264 C2177 C2190 C2201 C2211 C2221 C2231 C2241 C2255 C2265 C2178 C2192 C2202 C2212 C2222 C2232 C2242 C2256 C2266 UDIs: 00763000074104, 00763000132378, 00763000074128, 00763000134488 00763000081003, 00763000074067, 00763000168605, 00763000074135, 00763000134518, 00763000081041, 00763000135829, 00763000081102, 00763000074050, 00763000074098, 00763000135836
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.