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U.S. Department of Health and Human Services

Class 2 Device Recall Oarm" Imaging System

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  Class 2 Device Recall Oarm" Imaging System see related information
Date Initiated by Firm November 15, 2019
Date Posted December 31, 2019
Recall Status1 Terminated 3 on September 19, 2023
Recall Number Z-0767-2020
Recall Event ID 84441
510(K)Number K173664  K151000  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Code Information 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
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.-Littleton
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact
978-698-6000
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action On November 15, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: MEDICAL DEVICE CORRECTION O-arm" O2 Imaging System Dear Healthcare Professional: Medtronic has determined through internal testing that there is a potential for navigational inaccuracy when utilizing the O-armTM O2 Imaging Systems auto-registration feature, when used in conjunction with an Image-Guided Surgery System for a specific set of O-armTM O2 Imaging System serial numbers. A list of potentially affected systems is provided in Table 1 of this letter. Due to loosening of an internal motor drive belt over extended number of uses, image rotation may occur relative to patient positioning data. Inaccuracy may occur when the O-arm registration information is transferred to an Image-Guided Surgery System to be used in navigation, utilizing the rotated images. Navigational inaccuracies are inherent in the use of any Image-Guided Surgery System utilizing an O-armTM O2 Imaging System, but the potential for inaccuracy may be higher if image rotation occurs in an affected system. This letter provides awareness of this issue and reinforces existing instructions within the O-arm" O2 Imaging System User Manual (IFU) that allow for identification of the issue if it occurs. This issue does not involve the O-arm 1000 Imaging Systems. Issue Background and Summary: The O-arm" O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. Medtronic has determined that if the gantry tractor motor drive belt loosens over extended number of uses, it can 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
Quantity in Commerce 90
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = MEDTRONIC INC.
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