Events

Powered Wheelchairs Joystick 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Red Milawa Pty Ltd T/A Magic Mobility 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-00497-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-05-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00497-1
  • 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
    Magic mobility has been notified of a component issue resulting in the direct actuator control switching, through the jack input socket, to not function correctly.This issue may cause either an incorrect switch/actuator operation or an inoperable external switch/actuator. at the time of dispatch from magic mobility, any wheelchairs fitted with this joystick did not require the use of the jack input socket. the wheelchairs performance is not compromised in its despatched state.However, if in the future, a client wishes to use the jack for a switch, then the jack may not work correctly. this issue would be detected immediately and therefore poses no safety risk.
  • 조치
    Magic Mobility has identified and quarantined all affected serial numbers. Those units currently with customers are identified and a replacement scheme for the affected component has been initiated. Magic Mobility will be contacting affected customers directly.

Device

Powered Wheelchairs Joystick
  • 모델명 / 제조번호(시리얼번호)
    Powered WheelchairsJoystickPart Number: D51581 R-NET CJSM-L-SWSerial Numbers: BN18032803, BN18032873 and BN18032894ARTG Number: 118288
  • Manufacturer
    Red Milawa Pty Ltd T/A Magic Mobility

Manufacturer

Red Milawa Pty Ltd T/A Magic Mobility