Events

C-Series LiftsPrism Medical/Waverly Glen FSN-0016A 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Rehab Assist 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-2017-RN-01442-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01442-1
  • 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
    Rehab assist has been made aware by prism medical usa (a division of handicare), that during an internal cycle testing of c-series lifts it is determined that the c-series lift straps for lifts manufactured between april 25, 2017 and june 12, 2017 may wear prematurely at max load (625lbs). the root cause has been identified as a supplied component that was not to specification. if the strap wears during use there is a potential risk for the person being supported by the lift to drop.There have been no known incidents of hoists in use, only in internal routine cyclical testing.
  • 조치
    Rehab Assist will be in contact with affected customers to arrange for replacement of affected devices. This recall action only relates to the serial numbers stated for this Sponsor.

Device

C-Series LiftsPrism Medical/Waverly Glen FSN-0016A
  • 모델명 / 제조번호(시리얼번호)
    C-Series LiftsPrism Medical/Waverly Glen FSN-0016AItem Numbers: 1-323100, 1-323211, 1-323149Model 323100 C450 Manual Traverse Serial Numbers C4M0018959 and C4M0018962Model 323211 C450 Manual Traverse Rev A Serial Number C4M0018956Model 323149 C450 Power Traverse Serial Number C4P0009806ARTG Number: 169639
  • Manufacturer
    Rehab Assist Pty Ltd

Manufacturer

Rehab Assist Pty Ltd