Device Recall Philips Bucky Diagnost 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    64128
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1450-2013
  • 사례 시작날짜
    2013-01-16
  • 사례 출판 날짜
    2013-06-17
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-10-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, x-ray, stationary - Product Code KPR
  • 원인
    An inspection of iatd (installation acceptance test document)ia sid (source image distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment.
  • 조치
    Philips Healthcare issued an Urgent Field Safety Notification on January 11, 2013, to advised users of issued and perform corrective action to the units. Field Service Engineer (FSE) will execute corrections and attach record to IATD file. Your proposed corrective action plan (CAP) for the Bucky Diagnost system involves two mandatory field actions including new testing for sites with missing documentation and correcting the table height measurements for systems where the incorrect measurement procedure was used. You have also revised your IATD document to improve instructions to the field engineer for table height measurements. In your March 28, 2013, letter, you proposed a 6 month timeframe for this corrective action, and in your May 9, 2013 email, you communicated that the field corrections were ongoing and would be completed by July 16, 2013. In your May 9, 2013 email, you also clarified that the recalls are to be completed free of charge to any affected customer, whether or not they have a service agreement with Philips Healthcare. Further questions please call (978) 687-1501.

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 334584 345869 349805 352617 375957/SN07000650 352645 355617 356954 363678 362217 362252 361021 364214 362429 361526 363545 363802 364816 366510 366090 367504 370290 370643 373506 372845 376998 383090 384688/SN07000603 386397/SN07000659 406161/SN08000556 386265/SN08000415 389969/SN08000090 381103/SN08000131 444254/SN09000380 406491/SN08000315 389383/SN08000100 447038/SN10000169 389970/SN08000092 406017/SN08000307 389972/SN08000080 389656/SN08000052 386679/SN08000051 390255/SN08000050 394368/SN08000196 396406/SN08000193 399529/SN08000297 401268/SN08000268 402249/SN08000323 399571/SN08000559 384510/SN07000618 402246/SN08000261 403330/SN08000296 403648/SN08000292 407890/SN08000377 405887/SN08000381 413307/SN08000521 413205/SN08000562 411311/SN08000528 419318/SN09000042 428504/SN09000200 413818/SN08000526 414461/SN08000518 414601/SN08000501 438511/SN10000166 414315/SN08000474 418205/SN08000568 419316/SN09000007 421970/SN09000058 422097/SN09000068 426137/SN09000109 430918/SN09000175 435194/SN09000234 439546/SN09000334 439739/SN09000346 436337/SN09000251 438835/SN09000295 439098/SN09000294 439817/SN09000318 443072/SN09000363 443231/SN09000368 442855/SN09000357 443453/SN09000378 456506/SN10000167 449719/SN10000034 448152/SN10000013 448150/SN10000072 449717/SN10000068 450554/SN10000096 451156/SN10000059 456283/SN10000272 456082/SN10000174 458580/SN10000196 459495/SN10000212 460074/SN10000260 460485/SN10000228 460757/SN10000290 461677/SN10000302 461229/SN10000218 462389/SN10000252 463385/SN10000344 465974/SN10000320 468064/SN10000347 466164/SN10000336 468078/SN11000032 468518/SN10000353 470291/SN10000374 471046/SN10000386 471701/SN11000054 483054/SN11000246 476276/SN11000045 480210/SN11000126 483867/SN11000298 483244/SN11000199 486144/SN11000217 488176/SN11000244
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the country of Canada.
  • 제품 설명
    Philips BuckyDiagnost Radiographic. || Catalog Numbers: || 704031, 704032, 704035, 704060, 704062 || This system is used for making x-ray exposures for diagnostics
  • Manufacturer

Manufacturer

  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
  • Source
    USFDA