THERMOPHORE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 BATTLE CREEK EQUIPMENT 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
    140634
  • 사례 위험등급
    III
  • 사례 시작날짜
    2016-11-03
  • 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
    The issue was that the product fails prematurely when misused. the failure is specifically in the area where the electric cord meets the strain relief/switch. in cases where a user repeatedly bends and stresses the cord at a sharp/tight angle the cord may wear leading to a quick spark when the wire inside the cord fails. this then may lead to a visible spark small amounts of smoke or small amounts of carbon residue when it fails. the failure does not have any likelihood of injuring the user. this failure mode has been seen in less than one-hundredth of one percent (.09%) of units in the field.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 095 (Lot serial: NA); Model Catalog: 096 (Lot serial: NA); Model Catalog: 097 (Lot serial: NA)
  • 제품 설명
    THERMOPHORE
  • Manufacturer

Manufacturer