STRYKER S3 MED/SURG BED (MODEL 3002S3) 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 STRYKER CANADA LP 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
    82314
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-12-02
  • 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
    Stryker medical has identified a potential issue associated with secure ii and s3 med/surg beds built between april 2nd 2005 and july 26th 2011. the affected beds have the potential to experience damage to the foot end cover and/or power coil cable due to reduced clearance between the foot end cover and foot end lift header.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 3002 S3 EX (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002-000-000S3 (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 CUSTOM (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 ZX-SB (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 ZOOM (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 KCL (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 EX (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002-000-000 (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 S3 PATRIOT (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 S3 CUSTOM (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 S3 SIGNATURE (Lot serial: MFG BTW 2005/4/2 & 2011/7/26); Model Catalog: 3002 S3 ZOOM (Lot serial: MFG BTW 2005/4/2 & 2011/7/26)
  • 제품 설명
    S3 MED/SURG BED
  • Manufacturer

Manufacturer

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