Events

W & H Foot Control - S-N1/S-N2 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 A-DEC Australia 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-00006-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00006-1
  • 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
    A-dec has been made aware of a potential malfunction with certain w&h; foot controls. the foot control might not switch back to zero position when the pedal is released. consequently, the motor keeps rotating. if this happens during automatic thread cutting or automatic screwing-in of implants, it can, in the worst case, lead to a serious injury of the patient. so far, no incident has been reported.
  • 조치
    A-Dec will contact affected customers to arrange replacement foot controls to be provided. In the interim, the affected products must not be used for thread cutting and screwing in of implants. These operations have to be conducted manually.

Device

W & H Foot Control - S-N1/S-N2
  • 모델명 / 제조번호(시리얼번호)
    W & H Foot Control - S-N1/S-N2Multiple Affected Serial NumbersARTG 125363 (ADEC AUSTRALIA - Implantmed (various models) - Drill/saw system, dental)
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA