OMNIBED 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 DATEX-OHMEDA (CANADA) 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
    27286
  • 사례 위험등급
    II
  • 사례 시작날짜
    2005-06-06
  • 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
    Manufacturer has received reports that a potential exists for unintenional movement of the elevating base foloowing a mains power interruption and may compromise patient safety.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: OMNIBED (Lot serial: HDGJ50060 HDGJ50070); Model Catalog: OMNIBED (Lot serial: HDGH60848 HDGJ50057); Model Catalog: OMNIBED (Lot serial: HDGH60907 HDGH60947); Model Catalog: OMNIBED (Lot serial: HDGH60247 HDGH60802); Model Catalog: OMNIBED (Lot serial: HDGH60468 HDGH60469); Model Catalog: OMNIBED (Lot serial: HDGD50224 HDGG60109); Model Catalog: OMNIBED (Lot serial: HDGH60203 HDGG55045); Model Catalog: OMNIBED (Lot serial: HDGH60110 HDGH60175); Model Catalog: OMNIBED (Lot serial: HDGG60278 HDGH60030); Model Catalog: OMNIBED (Lot serial: HDGG60261 HDGG60268); Model Catalog: OMNIBED (Lot serial: HDGE50259 HDGG60148); Model Catalog: OMNIBED (Lot serial: HDGG54355 HDGG55019); Model Catalog: OMNIBED (Lot serial: HDGG54294 HDGG54351); Model Catalog: OMNIBED (Lot serial: HDGG54206 HDGG54295); Model Catalog: OMNIBED (Lot serial: HDGF54048 HDGG54203); Model Catalog: OMNIBED (Lot serial: HDGF53048 HDGF54150); Model Catalog: ELEVATING BASE (Lot serial: HDHG54225 HDHG54270); Model Catalog: ELEVATING BASE
  • 제품 설명
    OMNIBED
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • Source
    HC