Events

ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Permobil 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-2017-RN-00400-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00400-1
  • 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 problem was discovered internally with a supplied component for the affected products listed above. when a smart check by roho (smart check), model number smartcheck-01, is used to perform a smart setup with one of the affected cushions, the nonconforming part may adversely affect the setup process resulting in an improper cushion setup. sitting on an over inflated or under inflated sensor ready cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.(please note that this risk is not present when the sensor ready cushion is used without the smart check nor is the risk present when the sensor ready cushion is used with the smart check and the setup is performed using the optional setup mode).
  • 조치
    Permobil is advising users to return affected stock to their distributor. Distributors are requested to then contact Permobil to organise a replacement of the affected stock.

Device

ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology
  • 모델명 / 제조번호(시리얼번호)
    ROHO High Profile and Mid Profile Single Compartment Cushion with Sensor Ready Technology Multiple Model NumbersSerial Numbers between A2920163 and A3185287Production dates from 8 January 2016 to 28 February 2017ARTG Number: 111106
  • Manufacturer
    Permobil Australia

Manufacturer

Permobil Australia