Events

Recall of Device Recall BrightView XCT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76183
  • Event Risk Class
    Class 2
  • Event Number
    Z-1186-2017
  • Event Initiated Date
    2016-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152472
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, tomography, computed, emission - Product Code KPS
  • Reason
    The intended use listed in the english and localized language ifus for brightview xct systems did not match the intended use documented in the 510k submission.
  • Action
    All customers were notified via certified mail with return receipt. International customers were notivied via Philips employees. A field change order was initiated. Non-responders will be followed up on. Lastly, effectivenss checks will be conducted.

Device

Device Recall BrightView XCT
  • Model / Serial
    6000013 6000025 6000029 6000036 6000038 6000045 6000051 6000065 6000006 6000070 6000074 6000072 6000078 6000081 6000083 6000084 6000086 6000090 6000113 6000127 6000173 6000174 6000185 6000182 6000188 6000183 6000187 6000186 6000201 6000215 6000236 6000234 6000246 6000296 6000332 6000334 6000351 6000368 6000370 6000380 6000012 6000152 6340009 6000011 6000024 6000175 6000031 6000253 6000042 6000052 6000030 6000002 6000004 6000069 6000076 6000142 6000004A 6000122 6000016 6000158 6000189 6000093 6000005 6000095 6000092 6000022 6000035 6000019 6000023 6000010 6000111 6000040 6000056 6000060 6000057 6000026 6000054 6000033 6000028 6000114 6000003 6000049 6000059 6000110 6000020 6000062 6000058 6000162 6000018 6000043 6000064 6000071 6000027 6000037 6000085 6000047 6000017 6000015 6000063 6000061 6000048 6000055 6000091 6000044 6000106 6000100 6000067 6000102 6000096 6000286 6000103 6000088 6000107 6000068 6000041 6000050 6000104 6000077 6000066 6000089 6000094 6000099 6000130 6000117 6000080 6000097 6000087 6000134 6000073 6000079 6000053 6000105 6000244 6000101 6000116 6000218 6000121 6000148 6000108 6000138 6000143 6000098 6000150 6000082 6000118 6000123 6000120 6000277 6000147 6000144 6000128 6000119 6000109 6000112 6000208 6000115 6000125 6000209 6000288 6000139 6000160 6000159 6000140 6000129 6000184 6000145 6000146 6000161 6340008 6000141 6000131 6000135 6000132 6000361 6000151 6000133 6000238 6000191 6000155 6000149 6000153 6000156 6000163 6000136 6000254 6000257 6000177 6000154 6000270 6000225 6000170 6000196 6000126 6000157 11000021 6000165 6000164 6000167 6000190 6000168 6000166 6000169 6000172 6000178 6000405 6000353 6000214 6000198 6000197 6000231 6000180 6000193 6000192 6000213 6000176 6340010 6000179 6000194 6000171 6000203 6000195 6000199 6000204 6000233 6000212 6000200 6000181 6000360 6000202 6000217 6000412 6000205 6000210 6000227 6000272 6000211 6000230 6000219 6000220 6000229 6000228 6000237 6000235 6000207 6000206 6000250 6000222 6000226 6000046 6000331 6000223 6000221 6000287 6000240 6000224 6000216 6000014 6000232 6000239 6000283 6000249 6000258 6000245 6340011 6000256 6000241 6000278 6000242 6000243 6000266 6000285 6000247 6000259 6000251 6000263 6000284 6000345 6000260 6000265 6000279 6000255 6000262 6000269 6000276 6000274 6000252 6000271 6000268 6000267 6000312 6000261 6000273 6000006A 6000264 6000280 6000281 6000290 6000311 6000289 6000275 6000325 6000310 6000309 6000416 6000335 6000356 6000307 6000302 6000292 6000291 6000303 6000294 6000295 6000282 6000321 6000297 6000300 6000320 6000305 6000301 6000314 6000298 6000344 6000364 6000306 6000308 6000315 11000111 6000338 6000318 6000317 6000299 6000316 6000293 6000341 6000313 6000319 6000330 6000337 6000350 6000326 6000357 6000328 6000327 6000385 6000324 6000322 6000336 11000082 6000329 6000304 6000323 6000339 6000343 6000377 6000403 6000348 6000346 6000349 6000378 6000347 6000367 6000371 6000383 6000352 6000366 6000354 6000355 6000358 6000359 6000362 6000365 6000404 6000363 6000376 6000411 6000393 6000381 6000407 6000369 6000408 6000420 6000401 6000387 6000340 6000422 6000373 6000372 6000333 6000379 6000417 6000375 6000388 6000384 6000390 6000400 6000382 6000399 6000394 6000395 6000389 6000386 6000409 6000396 6000342 6000424 6000425 6000423 6000391 6000392 6000402 6000398 6000428 6000406 6000410 6000414 6000413 6000427 6000421 6000418 6000374 6000426 6000415 6000419 6000075 6000032 6000039
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were distributed in the following states: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, & WI. Product was distributed internationally to the following countries: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Saudia Arabia, Slovakia, South AFrica, Apain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
  • Product Description
    BrightView XCT
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA