Events

Medela Breast Pump Powered - Detachable Wall Plug 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Medela AG 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
    20526
  • 사례 시작날짜
    2016-08-19
  • 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: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
  • 원인
    The unit is composed of two parts: (1) a detachable wall plug; and (2) the power adapter itself, with cord attached., there are three versions of the wall plug. only one is affected. in rare cases, one version of the detachable wall plug supplied with the medela breastpump could split exposing a live wire and creating a risk of electrick shock.
  • 조치
    Product to be returned to supplier

Device

Medela Breast Pump Powered - Detachable Wall Plug
  • 모델명 / 제조번호(시리얼번호)
    Model: 099 0273; 099.0018 (AC Power Adapter) 040.0011; 040.0011-1; 042.0014; 030.0040; 030.0040-1; (Breast Pumps), Affected:
  • Manufacturer
    Medela AG

Manufacturer

Medela AG