C-series carry bars (used with C300, C450 Manual, C625 ceiling lifts/hoists) 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-2016-RN-01200-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-14
  • 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
    Some c-series carry bars are attached to the track using a plastic swivel. if the plastic swivel in these bars becomes damaged there is the potential for it to separate from the carry bar, resulting in a patient fall. rehab assist will supply a free metal insert to be placed inside affected carry bars to prevent separation if the plastic swivel becomes damaged.There have been nine incidents worldwide in which the plastic swivel mechanism has been reported as damaged. no incidents have been reported in australia and there have been no injuries reported as a result of this issue.
  • 조치
    Rehab Assist is advising distributors to contact all end users and inspect the swivels to determine if there are any damaged swivels in use. Customers are advised to inspect the swivel for damage or contact their distributor to arrange for a technician to do an inspection. If there is no damage the lift can continue to be used as normal. The metal insert should be installed as soon as practicable. If the swivel appears damaged, do not use the lift until the metal insert has been inserted. Wherever the plastic swivel is damaged, users are also advised to purchase and replace the carry bar as soon as possible. For more details, please see https://www.tga.gov.au/alert/rehab-assist-c-series-ceiling-hoists .

Device

  • 모델명 / 제조번호(시리얼번호)
    C-series carry bars (used with C300, C450 Manual, C625 ceiling lifts/hoists)Models Affected: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, 360757 (identifiable by a black plastic swivel/puck)ARTG Number: 169639
  • Manufacturer

Manufacturer