Events

Enterprise 8000 Electrical Bed 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Arjo Australia 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-2018-RN-00105-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00105-1
  • 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 become aware of the potential for loose brake pedal screws (part number s1306) which are responsible for connecting the brake pedal with the base frame of the bed and keeping the brake in the correct position. this issue of loose screws is visible to users. there is no evidence to suggest that this anomaly is related with any potential risk to users.
  • 조치
    Arjo is advising users to inspect the beds to determine if the screws are loose on the brake mechanism. If users see that the screw is not tightened fully, it means thatthe device is affected by this correction. Check the castor operation, paying attention to steering and/or braking function. If users detect small movements between the parts and loose movement between braking system, it means the device may be affected by this correction. Arjo will be inspecting the affected devices and replacing the affected screws during the next service visit. Users that undertake serving of their own devices are advised to unscrew the old screw S1306 and replace with new one, by use the torque wrench with 10.2 Nm torque.

Device

Enterprise 8000 Electrical Bed
  • 모델명 / 제조번호(시리얼번호)
    Enterprise 8000 Electrical BedModel Numbers: 5000, 8000, 9000, E5000X, E8000X, E9000XARTG Number: 283224(Arjo Australia - Bed, general-purpose, electrical)
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA