CMAX SURGICAL TABLE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 STERIS CANADA INCORPORATED 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
    82310
  • 사례 위험등급
    II
  • 사례 시작날짜
    2010-09-07
  • 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
    Steris corporation has learned that cmax surigical tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. this could result in the table moving into an unexpected tilt position when the "level" button is depressed on the hand control keypad. the likelihood of this event occurring is remote as the cmax surgical table opertor manual states to always connect the ac power cord to an appropriate ac receptacle as often and as long as possible with the main power switch set to on.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: CMAX 110 (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 110 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832050 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832051 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832JEJ (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 220 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832050 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832050 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: CMAX 110 (Lot serial: S/N: 0428208115 TO 0417309157)
  • 제품 설명
    CMAX SURGICAL TABLE
  • Manufacturer

Manufacturer

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • Source
    HC