Events

Medifab Shuttle Discovery System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Medifab Medical Fabrication 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
    19187
  • 사례 시작날짜
    2015-10-06
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Medifab Medical Fabrication, 32 Detroit Drive, Izone Business Hub, Rolleston 7675
  • 원인
    The manufacturer has identified two potential issues relating to the backrest and the tilt in space locking plunger should the vehicle used to transport the end user in the discovery buggy be involved in an accident., 1/ there is potential for the s tubes to come out of the mounting block, 2/ there is potential that the discovery seat may tilt back due to the tilt in space plungers not being engaged in the plastic slides.
  • 조치
    Product to be modified

Device

Medifab Shuttle Discovery System
  • 모델명 / 제조번호(시리얼번호)
    Model: 2006-0010-000, Affected: JS-06-14-DS-**, JS-15-14-DS-**, JS-18-14-DS-**, JS-23-14-DS-**, JS-45-14-DS-**, JS-46-14-DS-**, ML-8-15-DS-**, ML-13-15-DS-**, ML-16-15-DS-**, ML-17-15-DS-**, ML-18-15-DS-**, 61427, 61738
  • Manufacturer
    Medifab Medical Fabrication

Manufacturer

Medifab Medical Fabrication