medical Class II Updated 2020-01-08

Medtronic Navigation, Inc.-Littleton recalls O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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
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
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related medical Recalls

Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cathete

2022-08-31 · The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Mckesson Medical-Surgical Inc. Corporate Office recalls MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, w

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (

2022-08-31 · Inaccurate Distance and Area measurements with use of Global Stack viewport.

Mckesson Medical-Surgical Inc. Corporate Office recalls B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY,

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.