Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver Controls 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Invacare 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-2013-RN-00977-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-04
  • 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
    Invacare has identified a defect in a small percentage of crimped wire connections in certain joysticks which could result in oxidation leading to the slowdown of wheelchair speed performance over time. in a very small percentage of instances, the power wheelchair may slow down relative to the commanded speed and then recover, creating an unintended acceleration. the unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects, which can lead to bruising, pinched fingers, and pinched hands.
  • 조치
    Invacare is providing distributors with two options to correct the affected joystick. 1) Invacare will supply the distributors with the correction kit for each affected joystick, with instructions on how to return the affected joysticks to Invacare. 2) Invacare will engage a third party to complete the correction. Distributors are required to provide the details for end users to the third party in order to correct the affected joysticks. Invacare will correspond with end users directly if this option is selected. For more details, please see http://www.tga.gov.au/safety/alerts-device-invacare-131011.htm This action has been closed-out on 11/04/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Invacare Power Wheelchairs with affected SPJ+ Joysticks and MK6i Driver ControlsSerial numbers: 06JXXXXXXX to 13CXXXXXXX (the first two digits represent the year and the first letter represents the month i.e., A=January, B=February etc)Affected SPJ+ Joystick models are manufactured between 9 September 2009 to 21 March 2013 and MK6i Driver Controls (excluding all ASL, Sip-n-Puff and Switch control systems) are manufactured between 1 October 2006 to 21 March 2013ARTG Number: 160385
  • Manufacturer

Manufacturer