SIM System with SIM dock power supply model Franmar FRA012-S05-I 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Simavita Aust 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-2015-RN-00076-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-03
  • 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
    Simavita has recently received notification from their third party supplier that the plug adaptor, which is provided together with the sim dock power supply, has a design fault. under some circumstances, one of the pins from the plug adaptor may detach during removal from the power point and remain protruding from the power point creating an electrocution hazard.
  • 조치
    Customers are advised to:- 1. Identify the location of the SIM dock power supplies at their facility; 2. DO NOT unplug any of these power supplies that are currently plugged into a power point. The risk of electrocution only occurs where the pin has become detached from the plug adaptor & remains in the power point. 3. Immediately notify internal maintenance personnel in order to carry out safe removal of the power supplies from each outlet. Following safe removal all units must be quarantined until the product correction has been carried out; 4. Where one of these power supplies is not currently plugged into a power point, DO NOT plug in & use that power supply & quarantine the units as per internal procedures; 5.Immediately inspect any power points for the above fault in locations where it is known this device is regularly used & notify appropriate internal personnel in the event this anomaly is identified; and 6. Share this Notification internally to all appropriate staff. This action has been closed-out on 18/07/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    SIM System with SIM dock power supply model Franmar FRA012-S05-I ARTG Number: 227029
  • Manufacturer

Manufacturer