Events

Depuy Synthes Universal Battery Charger II (UBC II) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes 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-2016-RN-00175-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00175-1
  • 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
    The ubc ii has a component which may fail prematurely due to a manufacturing defect. if the component fails, the charger’s firmware recognises the malfunction and prevents batteries from being charged. the blue led on the front of the charger will flash to indicate that the device must be sent in for repair, in accordance with the user’s manual. when component failure occurs, the device firmware causes the ubc ii to enter “safe mode” which prevents the batteries from charging; this could potentially lead to a surgical delay.
  • 조치
    JJM is advising users to quarantine any affected stock prior to return and replacement. Users are advised to use alternate chargers or non-battery operated tools until a replacement is received.

Device

Depuy Synthes Universal Battery Charger II (UBC II)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes