3M Surgical Clipper 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 3M Australia Pty Ltd 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
    RC-2018-RN-00151-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-13
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    3m australia is notifying all users of an added product warning, stressing the importance of following proper clipper charging practices as documented in the instructions for use. current charging instructions recommend leaving the clipper body in the drop- in charger in between uses.Failure to follow proper charging practices can result in lithium-ion battery degradation, characterised by excessive heat during operation or failure to properly charge. in rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy which may potentially result in patient/user burns, or electrical shocks. there have been three reported instances overseas where users have experienced electric shocks.3m is adding the following product warning to emphasise the importance of proper charging practices: “warning: to avoid potential battery degradation, charge the clipper after each use and store in the drop-in charger stand when not in use.”.
  • 조치
    3M is advising users to inspect any devices, and discard any that do not hold charge or is uncomfortably hot to touch during use. Affected devices will be replaced by 3M. Unaffected devices are to be stored in the drop in charger stand when not in use.

Device

  • 모델명 / 제조번호(시리얼번호)
    3M Surgical ClipperModel Number: Professional 9681All lot numbers affectedARTG Number: 101095(3M Australia - Clipper, hair, electric)
  • Manufacturer

Manufacturer