Class 2 Device Recall

• Date Initiated by Firm: March 10, 2008
• Date Posted: September 05, 2008
• Recall Status: Terminated on December 10, 2011
• Recall Number: Z-2008-2008
• Recall Event ID: 48137
• 510(K)Number: K942837
• Product Classification: System, Tomography, Computed, Emission - Product Code KPS
• Product: DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system.
• Code Information: 211 0000000DSTX002 0000000DSTX003 0000000DSTX004 178 174 156 119 000000000A/255 000000000B/171 183 138 0000000DSTX008 000000000B/175 246 000000000D/207 00A108/168/331 0000000DSTX020 0000000DSTX010 000000000D/127 126 0000000000A252 0000000DSTX019 UNK10023750070 0000000DSTX016 204 000000000A/217 1461 000000000A/213 167 209 000000000A/241 000000000A/242 9833 154 9759 00000000097/63 00000000097/04 128 000000000A/166 112 0000271/119/28 000000000A/249 0000000136/300 0000000000A117 0000000#258097 9745 000226/116/273 149 00000000098/32 208 9747 000000000A/223 9723 9806 135 106 210 0000000000B186 132 0000000000A162 9737 142 159 000131/288/295 229 000000000A/190 000000000A/219 9756 158 000000000A/238 000000000A/195 9549 000000000A/191 9758 0000000DSTX014 0000000DSTX017 195 000000XL129601 0000000DSTX015 150 165 000000XL069502 134 225 A/229 222 000000DSTXL001 237 111 SMSA100801 122 194 000282/123/284 000304/144/308 000A104/A157/3 98410147 00000000A/1035 000250/109/257 000250/109/257 180 UNKNOWN 000000000A/189 212 0000000000A226 223 000A202/A193/C 000113/259/275 113 181 164 A/245 A/249 000A102/161/32 000160/A101/32 000285/130/290 000293/135/297 000J2/229/A463 000182/124/357 000A205/200/C3 151 99370248 240 215 000000000A/195 152 168
• Recalling Firm/ Manufacturer: GE Healthcare; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: GE Healthcare has recently became aware of a cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient safety.
• FDA Determined Cause: Device Design
• Action: Field Modification Instructions (FMI No: 40815) will be issued to the field for the DST-XL product to install an arm or gantry rotation motor's brake. The customers letters "Product Safety Notification" dated March 10, 2008, have been distributed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter informs the customers of the safety issue, affected product, safety instructions, product correction and contact information. If you have questions, please contact GE Healthcare within the US or Canada at 1-800-437-1171 or outside the US the telephone number at 1-262-896-2890.
• Quantity in Commerce: 127
• Distribution: AL, AR, CA , CO, DE , FL, IA, IL, KS, MA, MI, MS, NC , NJ, NY, OH, OK, PA , SC, TN, TX , VA, VT, WA United Kingdom, Belgium, Switzerland, Russia Federal Sweden, France, Italy, Spain, Germany Federal, Norway, Portugal, Netherlands, Saudi Arabia, Iran, India, Canada, Argentina, Taiwan, China, Bangladesh, Austria.
• 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 = KPS and Original Applicant = SOPHA MEDICAL SYSTEMS, INC.