Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medifab 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-2015-RN-00951-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-30
  • 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
    Medifab have identified two safety issues relating to the backrest and the tilt in space locking plunger on shuttle discovery.1. on some discovery seats the rear “s tubes” are moving in and out excessively when the backrest is rocked backwards and forwards. although some movement is normal, there is potential for the s tubes to come out of the mounting block should the motor vehicle used to transport the end user in the discovery buggy be involved in an accident. 2. on some discovery seats the tilt in space plungers are not engaging in the plastic sides. there is potential that the discovery seat may tilt back should the motor vehicle used to transport the end user in the discovery buggy be involved in an accident. there have been no reported incidents in relation to these issues.
  • 조치
    A Technician or Product Consultant will contact customers to arrange a suitable time to carry out the corrective actions. For more details, please see https://www.tga.gov.au/alert/shuttle-discovery-seat . This action has been closed-out on 28/02/2018.

Device

  • 모델명 / 제조번호(시리얼번호)
    Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability)Product Code: 2006-0010-000Batch #: 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-**6142761738ARTG #: 160111
  • Manufacturer

Manufacturer