Events

REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Rex Bionics Australia Pty 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-00852-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00852-1
  • 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
    Rex bionics has been made aware of a patient injury, relating to incorrectly securing the heel stops on the rex. the patient suffered bilateral upper and lower tibial and bilateral lower fibular fractures following a spasm which resulted in unsecured heel stops moving backwards. the injuries may have been exacerbated by the use of ankle foot orthoses (afo) which restricted the users’s range of motion greater than required by rex.The heel stop must be correctly aligned with the measurement on the footplate corresponding to the user’s ankle to hind-foot measurement. once adjusted, the heel stop must be secured by tightening the locking nut. failure to do this may cause the user’s leg to move out of alignment, which may result in serious injury.
  • 조치
    Rex Bionics is advising users of the importance of the correct heel stop adjustment, and securing using the tightening of the locking nut. Revised Instructions for Use (IFU) will be provided regarding the heel stops and the use of Ankle Foot Orthoses which limit the range of motion for a patient. This action has been closed out on 16 June 2017.

Device

REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-...
  • 모델명 / 제조번호(시리얼번호)
    REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes) All devices affectedARTG Numbers: 237572, 271519
  • Manufacturer
    Rex Bionics Australia Pty

Manufacturer

Rex Bionics Australia Pty
  • Source
    DHTGA