Class 2 Device Recall BrightView XCT

• Date Initiated by Firm: June 10, 2019
• Create Date: July 22, 2019
• Recall Status: Terminated on July 24, 2020
• Recall Number: Z-2011-2019
• Recall Event ID: 83201
• 510(K)Number: K080927
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: BrightView XCT , Model Number 882482
• Code Information: Serial Numbers: 6000241 6000290 6000291 6000292 6000306 6000289 6000304 6000374 6000318 6000219 6000054 6000089 6000194 6000165 6000199 6000171 6000053 6000352 6000203 6000396 6000094 6000229 6000391 6000033 6000060 6000220 6000057 6000164 6000167 6000195 6000204 6000235 6000043 6000082 6000295 6000402 6000056 6000237 6000355 6000349 6000317 6000021 6000206 6000026 6000228 6000015 6000163 11000021 6000325 6000022 6000210 6000338 6000012 6000037 6000269 6000047 6000330 6000184 6000128 6000132 6000251 6000310 6000309 6000416 6000077 6000130 6000339 6000066 6000131 6000020 6000147 6000123 6000115 6000126 6000276 6000109 6000081 6000083 6000086 6000246 6000332 6000201 6000036 6000187 6000051 6000351 6000185 6000188 6000084 6000127 6000070 6000183 6000006 6000038 6000045 6000065 6000074 6000380 6000234 6000159 6000334 6000296 6000174 6000173 6000182 6000013 6000113 6000090 6000072 6000078 6000368 6000370 6000025 6000029 6000215 6000186 6000236 6000363 6000406 6000240 6000145 6000212 6000407 6000389 6000233 6000129 6000121 6000303 6000333 6000319 6000271 6000342 6000211 6000367 6000224 6000156 6000300 6000320 6000041 6000262 6000293 6000307 6000329 6000354 6000216 6000255 11000082 6000274 6000227 6000064 6000248 6000400 6000384 6000101 6000062 6000398 6000100 6000238 6000133 6000190 6000010 6000337 6000105 6000336 6000202 6000371 6000049 6000181 6000103 6000265 6000222 6000032 6000346 6000321 6000226 6000141 6000067 6000068 6000075 6000273 6000365 6000362 6000168 6000418 6000125 6000166 6000169 6000359 6000427 6000205 6000280 6000281 6000048 6000055 6000061 6000341 6000358 6000350 6000421 6000157 6000326 6000155 6000249 6000044 6000315 6000120 6000385 5340007 6000193 6000099 6000299 6000027 6000079 6000017 6000139 6000247 6000426 6000410 6000102 6340008 6000347 6000176 6000414 6340010 6000305 6000039 6000252 6000264 6000260 6000294 6000343 6000268 6000323 6000392 6000428 6000267 6000223 6000425 6000423 6000424 6000298 6000138 6000154 6000242 6000243 6000314 6000413 6000050 6000297 6000207 6000230 6000098 6000144 6000254 6000257 6000270 6000096 6000302 6000357 6000328 6000200 6000258 6000376 6000192 6000059 6000097 6000379 6000111 6000005 6000259 6000278 6000035 6000375 6000221 6000119 6000282 6000415 6000261 7811_12 6000104 6000231 6000136 6000151 6000180 6000369 6000118 6000080 6000088 6000085 6000244 6000073 6000381 6000393 6000411 6000069 6000011 6000076 6000018 6000092 6000095 6000403 6000313 6000052 6000031 6000107 6000405 6000042 6000153 6000383 6000143 6000117 6000364 6000422 6000160 6000308 6000285 6000112 6000312 6000135 6000172 6000178 6000372 6000019 6000284 6000142 6000340 6000404 6000327 6000198 6000214 6000373 6000387 6000253 6000316 6000063 6000344 6000040 6000394 6000395 6000283 6000377 6000217 6000388 6000146 6000232 6000239 6000058 6000179 6340009 6000335 6000356 6000024 6000140 6000408 6000401 6340011 6000348 6000189 6000134 6000158 6000208 6000209 6000266 6000286 6000108 6000016 6000277 6000245 6000419 6000177 6000279 6000322 6000250 6000263 6000324 6000399 6000409 6000331 6000028 6000390 6000170 6000116 6000023 6000091 6000420 6000353 6000149 6000378 6000003 6000071 6000386 6000087 6000345 6000197 6000004A 6000114 6000150 6000148 6000122 6000360 6000366 6000106 6000272 6000110 6000196 6000152 6000218 6000030 6000382 11000111 6000287 6000004 6000005A 6000361 6000412 6000161 6000225 6000175 6000288 6000275 6000417 6000002 6000162 6000311 6000191 6000213 6000301
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Holly Wright Lee; 440-483-7600
• Manufacturer Reason for Recall: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Field Safety Notice Medical Device Correction letters dated 6/4/19 were sent to customers. Discontinue Use of the BrightView Handcontroller. Remove the handcontroller from the charging station and store in a secure location inaccessible by technicians, at least 20 meters (65 feet) away from the system and outside the imaging room. If 20 meters (65 feet) is not possible, then store the handcontroller in an area that is shielded, such as a hot lab. Do not dispose of the hand controller, as it will be needed once a solution is identified. Instead of the physical handcontroller, use the virtual handcontroller located on the touchscreen monitor attached to the gantry as shown in Figure 3. Philips Healthcare is distributing this FSN to all affected customers/users and will deploy a technical solution addressing the issue upon completion of the investigation. If you need any further information or support concerning this issue, please contact your local Philips representative: For SUPPORT in North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
• Quantity in Commerce: 427
• Distribution: Worldwide Distribution - US Nationwide
• 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 = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.