Events

Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171 FE and BA3180-171 FE. 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-0919-05
  • 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=39114
  • 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 Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 ...
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 374061 through 374065, 374489 through 374519, 374521 through 374531, 375262, 376203 through 376211, 376229 through 376236, 376268 through 376284, 376698, 377647, 377648, 380181, 381593, 382244, 382373 through 382382, 383163 through 383166, 384390 through 384399, 386463 through 386468, 387057 through 387066, 387977 through 388004, 388039 through 388046, 388049 through 388063, 388153 through 388195, 388515 through 388527, 388529, 388679 through 388681, 388728 through 388735 and 389410 through 389414.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171 FE and BA3180-171 FE.
  • Manufacturer
    Carroll Healthcare Inc.

Manufacturer

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