Events

Device Recall BrightView XCT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79088
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0511-2018
  • 사례 시작날짜
    2017-12-15
  • 사례 출판 날짜
    2018-02-03
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161314
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    System, tomography, computed, emission - Product Code KPS
  • 원인
    During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. the collimator may be partially supported by the cart (e.G. leaning against the cart), or it may fall/slide all the way to the floor.
  • 조치
    Philips sent an Urgent Field Safety Notice letter dated December 15, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Philips representative.

Device

Device Recall BrightView XCT
  • 모델명 / 제조번호(시리얼번호)
    Brightview XCT Model 882482 Serial Numbers :  6000241 6000290 6000291 6000292 6000306 6000289 6000304 6000374 6000237 6000317 6000235 6000318 6000167 6000194 6000229 6000391 6000352 6000220 6000054 6000060 6000195 6000204 6000206 6000295 6000203 6000043 6000082 6000402 6000056 6000026 6000228 6000171 6000355 6000089 6000033 6000053 6000094 6000093 6000165 6000199 6000349 6000219 6000396 6000163 11000021 6000325 6000022 6000015 6000020 6000047 6000130 6000184 6000330 6000147 6000123 6000077 6000128 6000251 6000066 6000131 6000132 6000338 6000310 6000309 6000269 6000210 6000012 6000037 6000416 6000339 6000276 6000115 6000126 6000109 6000113 6000051 6000351 6000201 6000332 6000013 6000368 6000370 6000215 6000127 6000236 6000006 6000038 6000045 6000065 6000173 6000084 6000187 6000186 6000070 6000183 6000185 6000188 6000090 6000072 6000078 6000182 6000074 6000036 6000334 6000380 6000296 6000246 6000081 6000083 6000086 6000025 6000029 6000174 6000234 6000363 6000406 6000389 6000233 6000224 6000121 6000145 6000342 6000156 6000300 6000211 6000212 6000303 6000333 6000367 6000407 6000320 6000240 6000129 6000319 6000271 6000041 6000262 6000293 6000307 6000329 6000354 11000082 6000255 6000216 6000337 6000274 6000227 6000256 6000384 6000064 6000398 6000101 6000133 6000238 6000400 6000062 6000222 6000100 6000190 6000103 6000265 6000336 6000181 6000010 6000105 6000371 6000032 6000346 6000226 6000321 6000141 6000067 6000068 6000075 6000273 6000350 6000281 6000168 6000359 6000061 6000427 6000166 6000169 6000048 6000055 6000362 6000358 6000125 6000280 6000418 6000341 6000421 6000205 6000365 6000157 6000326 6000155 6000249 6000044 6000120 6000315 6000385 6000299 6000027 6000079 6000193 6000099 600009 6000124 6000017 6000139 6000247 6000426 6000046 6000102 6340008 6000176 6000347 6000410 6000414 6000305 6340010 6000039 6000260 6000267 6000392 6000343 6000268 6000223 6000323 6000294 6000428 6000264 6000252 6000413 6000154 6000242 6000243 6000298 6000314 6000423 6000424 6000425 6000138 6000050 6000297 6000207 6000098 6000144 6000096 6000230 6000254 6000257 6000270 6000357 6000302 6000200 6000328 6000059 6000097 6000111 6000259 6000049 6000379 6000258 6000192 6000005 6000278 6000035 6000202 6000376 6000375 6000221 6000119 6000415 6000282 6000057 6000164 6000261 6000104 6000088 6000136 6000118 6000080 6000231 6000151 6000369 6000180 6000085 6000244 6000073 6000018 6000191 6000122 6000422 6000189 6000011 6000152 6000213 6000175 6000272 6000313 6000263 6000324 6000071 6000312 6000112 6000409 6000372 6000217 6000388 6000364 6000218 6000420 6000403 6000381 6000393 6000411 6000419 6000275 6000177 6000135 6000146 6000076 6000069 6000179 6000266 6000232 6000239 6000377 6000353 6000373 6000387 6000361 6000366 6000383 6000322 6000052 6000004 6000378 6000042 6000160 6000159 6000140 6000408 6000153 6000284 6000091 6000277 6000335 6000356 6000040 6000016 6000208 6000209 6000417 6000360 6000412 6000004A 6000390 6000198 6000214 6000114 6000316 6000245 6000172 6000178 6000143 6000285 6000108 6000087 6000345 6000386 6000107 6000116 6000063 6000344 6000023 6000028 6000279 6000058 6000197 6000331 6000149 6000327 6000401 6000196 6000002 6000134 6000158 6000394 6000395 6340009 6000162 6000311 6000019 11000111 6000382 6000283 6000142 6000024 6000031 6000253 6000110 6000030 6000161 6000250 6000288 6000117 6000003 6000308 6000106 6000348 6000286 6000150 6000287 6000405 6340011 6000225 6000399 6000404 6000340 6000092 6000095 6000148 6000170 6000014 6000006A 6000301 6000005A 5340007
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    BrightView XCT Model 882482 || Product Usage: || BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA