Events

Carroll Healthcare brand Spirit bed; models BH2180-111AE, BH2180-111PE and BH2180-111FE. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carroll 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
    32093
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0920-05
  • 사례 시작날짜
    2005-05-17
  • 사례 출판 날짜
    2005-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-11-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39115
  • 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
    Bed, Ac-Powered Adjustable Hospital - Product Code FNL
  • 원인
    The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
  • 조치
    Consignees were sent a fax on 5/17/05 advising them of the problem and instructing them to lock-out the HILO pendant function on the attendant control pad until the firm visits their facility and corrects their beds.

Device

Carroll Healthcare brand Spirit bed; models BH2180-111AE, BH2180-111PE and BH2180-111FE.
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 376078, 376079, 376155, 376156, 376219, 376220, 376223 through 376225, 376228, 376680 through 376683, 377067, 377262, 378422 through 378424, 378543 through 378552, 378698 through 378700, 378801 through 378806, 378811, 379168 through 379178, 379191, 379419 through 379421, 379472 through 379476, 379605 through 379611, 379719, 379720, 379831 through 379842, 379957 through 379959, 380047 through 380050, 380172 through 380180, 381130 through 381139, 381215, 381320 through 381326, 381416, 381589, 381590, 381595 through 381599, 381964, 381965, 382007 through 382010, 382167, 382168, 382171, 382172, 382283, 382422, 382764 through 383767, 383127, 383148, 383286 through 383288, 383484 through 383488, 383521, 383624, 383625, 383642, 383643, 383787, 383788, 384091 through 384100, 384225, 384226, 384480, 384727 through 384750, 384839, 384840, 385291 through 385297, 385752 through 385796, 385958, 386044 through 386063, 386327 through 386336, 386356 through 386361, 386366, 386412, 386435 through 386438, 386487 through 386492, 386511, 386530, 386570 through 386572, 386719 through 386724, 386733, 386746, 386776, 386926 through 386935, 386942, 386943, 387054 through 387056, 387495 through 387498, 387568, 387823, 388035 through 388038, 388207, 388468, 388542 through 388551, 388765 through 388771, 388796, 388877 through 388881, 389124, 389274, 389340 through 389389, 389417 through 389431 and 390437 through 390442.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Carroll Healthcare brand Spirit bed; models BH2180-111AE, BH2180-111PE and BH2180-111FE.
  • Manufacturer
    Carroll Healthcare Inc.

Manufacturer

Carroll Healthcare Inc.
  • 제조사 주소
    Carroll Healthcare Inc., 1881 Huron St, London Canada N6E1P5, Ontario
  • Source
    USFDA