Device Recall BV25 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems Sales & Service Region No. America 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
    29855
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1453-04
  • 사례 시작날짜
    2004-07-20
  • 사례 출판 날짜
    2004-09-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2006-02-09
  • 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, Mobile - Product Code IZL
  • 원인
    Potential for c-arm to move due to loose screws.
  • 조치
    Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.

Device

  • 모델명 / 제조번호(시리얼번호)
    For all devices:  Part #s 980762000001, 980762000101, 980762010001, 980762010101, 980762020001, 980762020201, 984910000031, 984910000101, 989600006051, 989600006091, 989600006281, 989600006282, 989600007041, 989600007731  Site #s 59630, 104099, 101968, 101961, 101964, 59628, 59631, 59632, 101967, 101963, X1118, X1178, X1463, X1346, X1190, X1465, X0532, X1455, X1452, X1239, X1060, 300026, 300027, 13695, 10305, 13047, 13587, 13663, 35451, 13552, 15281, 13298, 13687, 14152, 13626, 15189, 13542, 15067, 10407, 13144, 15063, 14164, 13498, 13222, 13233, 13301, 15175, 13150, 82476, 15316, 13272, 5153, 13602, 15074, 14129, 15083, 13630, 82475, 13445, 10018, 15091, 59693, 13964, 13938, 13236, 4013, 6674, 6749, 59454, 6815, 6737, 6630, 6765, 6787, 81887, 6848, 5160, 6492, 4258, 6658, 6830,  6304, 101929, 6618, 6692, 6748, 4115, 6307, 6677, 4065, 4290, 6868, 6729, 4125, 6537, 6724, 6708, 4170, 6561, 76866, 5162, 5159, 4224, 6745, 5055, 6589, 34132, 34149, 35419, 38965, 35170, 34088, 34749, 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The units are distributed to hospitals and medical centers throughout the U.S.
  • 제품 설명
    BV25 Mobile X-Ray System
  • Manufacturer

Manufacturer

  • 제조사 주소
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Hwy, Bothell WA 98021
  • Source
    USFDA