SPIRIT BED 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 INVACARE CONTINUING CARE GROUP 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
    19703
  • 사례 위험등급
    II
  • 사례 시작날짜
    2005-05-19
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Beds contain linak control box that may be faulty and cause the box to stop functioning and cause the external circuit to become thermally charged.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: BBH2180-111 PE (Lot serial: 387977 TO 388004); Model Catalog: BBH2180-111 AE (Lot serial: 387977 TO 388004); Model Catalog: BBH2180-111 FE (Lot serial: 387057 TO 387066); Model Catalog: BBH2180-111 PE (Lot serial: 387057 TO 387066); Model Catalog: BBH2180-111 AE (Lot serial: 387057 TO 387066); Model Catalog: BBH2180-111 FE (Lot serial: 386463 TO 386468); Model Catalog: BBH2180-111 PE (Lot serial: 386463 TO 386468); Model Catalog: BBH2180-111 AE (Lot serial: 386463 TO 386468); Model Catalog: BBH2180-111 FE (Lot serial: 384390 TO 384399); Model Catalog: BBH2180-111 PE (Lot serial: 384390 TO 384399); Model Catalog: BBH2180-111 AE (Lot serial: 384390 TO 384399); Model Catalog: BBH2180-111 FE (Lot serial: 383163 TO 383166); Model Catalog: BBH2180-111 PE (Lot serial: 383163 TO 383166); Model Catalog: BBH2180-111 AE (Lot serial: 383163 TO 383166); Model Catalog: BBH2180-111 FE (Lot serial: 382373 TO 382382); Model Catalog: BA3180-171 AE (Lot serial: 376078); Model Catalog: BA3180-151 FE (Lot serial:
  • 제품 설명
    SPIRIT BED
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • Source
    HC