Events

Molift Air 205 and 300 ceiling hoist (a powered lifting device) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Patient Handling 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-00975-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00975-1
  • 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 manufacturer has received a total of 4 reports where the bolt on the suspension coupling on molift air has become loose in the coupling. all reports came after technical testing and inspection. to date, no reports have been received regarding patient injury resulting from this issue. however, there is a potential risk for harm or injury if the bolt inside the coupling comes loose from the housing.
  • 조치
    Patient Handling will arrange to upgrade the device with a retainer safety ring that will prevent the bolt within the suspension coupling coming loose. Qualified service personnel will install the upgrade kits on all affected systems. Consumers are advised to contact the place of purchase to organise a qualified service technician to install the upgrade kit. For more details, please see https://www.tga.gov.au/alert/molift-air-ceiling-hoist .

Device

Molift Air 205 and 300 ceiling hoist (a powered lifting device)
  • 모델명 / 제조번호(시리얼번호)
    Molift Air 205 and 300 ceiling hoist (a powered lifting device)Molift Air 205Model Numbers: 2501205, 2501210, 2501215, 2501220Molift Air 300Model Numbers: 2501300, 2501310, 2501315, 2501320Distributed between May 2013 and January 2016ARTG Number: 229696
  • Manufacturer
    Patient Handling Pty Ltd

Manufacturer

Patient Handling Pty Ltd