Events

Device Recall BrightView 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-0512-2018
  • 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=161315
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Brightview Model 882480 Serial Numbers :  4000410 4000651 4000652 4000665 4000688 4000350 4000065 4000061 4000180 4000224 4000321 4000298 4000552 4000280 4000378 4000336 4000559 4000229 4000262 4000681 4000009 4000184 4000554 4000516 4000303 4000576 4000190 4000305 4000411 4000669 4000614 4000324 4000612 4000566 4000627 4000218 4000123 4000287 4000070 4000166 4000202 4000102 4000276 4000091 4000301-1 4000455 4000033 4000364 4000008 4000497 4000498 4000699 4000012 4000213 4000413 4000472A 4000581 4000469 4000648 4000510 4000454 4000335 4000436 4000353 4000418 4000491 4000571 4000197 4000555 4000518 4000544 4000500 4000592 4000617 4000005 4000379 4000451 4000533 4000602 4000137 4000343 4000030 4000540 4000316 4000342 4000408 4000421 4000495 4000511 4000664 4000317 4000338 4000604 4000682 4000647 4000341 4000057-OLD 4000389 4000290 4000283 4000312 4000328 4000375 4000560 4000366 4000417 4000051 4000372 4000151 4000422 4000195 4000088 4000381 4000071 4000003 4000549 4000487 4000056 4000006 4000466 4000550 4000346 4000683 4000483 4000301 4000158 4000223 4000129 4000045 4000057 4000557 4000567 4000370 4000536 4000029 4000607 4000067 4000068 4000032 4000423 4000039 4000031 4000620 4000678 4000601 4000122 4000286 4000294 4000395 4000672 4000348 4000613 4000655 4000390 4000419 4000462 4000463 4000464 4000638 4000296 4000199 4000096 4000281 4000288 10422 199 281 288 422 4000002 4000268 4000382 4000692 4000693 4000337 4000595 4000447 4000273 4000169 4000442 4000412 4000488 4000297 4000228 4000156 4000047 4000049 4000107 4000227 4000105 4000698 4000333 4000339 4000385 4000109 4000115 4000356 4000257 4000173 4000126 4000121 4000494 4000398 4000503 4000386 4000399 4000179 4000600 4000400 4000397 4000194 4000154 4000504 4000233 4000256 4000667 4000401 4000394 4000585 4000168 4000631 4000354 4000493 4000072 4000237 4000272 4000478 4340004 4000219 4000485 4000643 4000376 4000416 4000243 4000437 4000694 4000551 4000035 4000645 4000691 4000427 4000515 4000548 4000183 4000142 4000066 4000226 4000475 4000519 4000459 4000461 4000468 4000063 4000150 4000210 4000217 4000547 4000689 4000420 4000690 4000530 4000639 4000479 4000568 4000300 4000572 4000573 4000640 4000013 4000075 4000080 4000086 4000392 4000396 4000481 4000428 4000157 4000374 4000543 4000041 4000167 4000203 4000407 4000621 4000676 4000477 4000299 4000133 4000675 4000314 4000686 4000209 4000010 4000539 4000663 4000082 4000134 4000163 4000373 4000409 4000465 4000471 4000545 4000618 4000637 4000641 4000153 4000331 4000211 4000484 4340005 4000044 4000393 4000282 4000449 4000679 4000279 4000208 4000216 4000269 4000125 4000254 4000345 4000415 4000586 4000327 4000307 4000361 4000146 4000159 4000077 4000050 4000687 4000325 4000165 4000252 4000315 4000191 4000598 4000141 4000565 4000135 4000537 4000591 4000311 4000626 4000636 4000329 4000181 4000644 4000171 4000120 4000484A 4000441 4000054 4000110 4000653 4000590 4000100 4000520 4000323 4000403 4000406 4000489 4000277 4000306 4000332 4000635 4000270 4000302 4000046 4000214 4000615 4000187 4000660 4000383 4000633 4000322 4000212 4000628 4000034 4000232 4000668 4000480 4000430 4000553 4000467 4000221 4000127 4000259 4000670 4000193 4000222 4000289 4000597 4000439 4000542 4000531 4000588 4000358 4000330 4000508 4000310 4000371 4000501 4000609 4000616 4000116 4000452 4000058 4000521 4000059 4000064 4000482 4000384 4000528 4000177 4000506 4000278 4000089 4000139 4000130 4000564 4000578 4000674 4000083 4000583 4000225 4000267 4000563 4000587 4000117 4000053 4000662 4000526 4000207 4000118 4000103 4000556 4000247 4000326 4000174 4000248 4000642 4000696 4000182 4000456 4000060 4000522 4000448 4000099 4000246 4000175 4000524 4000630 4000155 4000367 4000360 4000492 4000037 4000230 4000308 4000236 4000143 4000285 4000505 4000206 4000684 4000164 4000004 4000650 4000671 4000473 4000405 4000235 4000242 4000680 4000318 4000561 4000149 4000073 4000240 4000606 4000610 4000304 4000584 4000580 4000460 4000263 4000347 4000632 4000265 4000368 4000055 4000349 4000658 4000351 4000388 4000589 4000558 4000106 4000144 4000444 4000292 4000098A 4000319 4000245 4000295 400054 4000470 4000666 4000111 4000148 4000076 4000443 4000575 4000654 4000251 4000108 4000657 4000659 4000562 4000535 4000435 4000357 4000677 4000453 4000377 4000387 4000446 4000608 40007060008 4000036 4000433 4000538 4000474 4000414 4000569 4000266 4000204 4000119 4000079 4000234 4000253 4000192 4000249 4000634 4000152 4000380 4000513 4000198 4000313 4000340 4000525 4000541 4000231 4000424 4000161 4000170 4000048 4000239 4000124 4000200 40007050005 40007060007 4000625 4000264 4000534 4000261 4000359 4000220 4000136 4000140 4000355 4000087 4000104 4000611 4000002 4000040 4000093 4000258 4000352 4000291 4000132 4000334 4000486 4000271 4000599 4000605 4000196 4000363 4000656 4000362 4000074 4000577 4000151-1 4000238 4000007 4000113 4000284 4000260 4000244 4000391 4000344 4000695 4000112 4000205 4000250 4000052 4000432 4000275 4000185 4000646 4000094 4000215 4000507 4000090 40000101 4000582 4000594 4000128 4000661 4000431 4000703001 4000523 4000078 4000425 4000062 4000145 4000011 4000426 4000440 4000529 4000450 4000509 4000241 4000320 40000092 4000603 4000496 4000532 4000502 4000255 4000593 4000490 4000293 4000434 4000619 4000438 4000095 4000499 4000623 4000517 4000624 4000402 4000162 4000574 4000476 4000629 4000649 4000685 4000596 4000160 4000546 4000622 4000186 4000189 4000445 4000429 4000274 4000697 4000673 4000038 4000404 4000176 4000114 4000309 4000138 4000188 4000369 4000178 4000043 4000002 3/4 4000081 40007030003 40007060006 4000579 4000527 4000201
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    BrightView Model 882480 || Product Usage: || BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
  • 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