Events

LIFEDOP 250 SYSTEM - PROBES 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES 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
    17960
  • 사례 위험등급
    III
  • 사례 시작날짜
    2017-10-06
  • 사례 국가
    Canada
  • 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
    The coopersurgical 2 mhz waterproof ob probe is for obstetrical use in the labor and delivery department for late term obstetrical examination associated with larger women. the product detects fetal heart beats as an aid for determining fetal viability. coopersurgical quality assurance program identified that the 2mhz is incorrectly labeled with the 3 mhz probe label on september 19 2017. the event was discovered internally during product complaint investigation.

Device

LIFEDOP 250 SYSTEM - PROBES
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: SDW (Lot serial: 2017070007); Model Catalog: SDW (Lot serial: 2017070005); Model Catalog: SDW (Lot serial: 2017070009)
  • 제품 설명
    Summit Doppler 2MHz Waterproof OB Probe
  • Manufacturer
    COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES

Manufacturer

COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES