Events

Philips MobileDiagnost wDR1 and 2, resistive arrestor strap 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems DMC GmbH 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
    18689
  • 사례 시작날짜
    2015-06-17
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    When the system is driven over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. the system can be stopped by releasing the drive handle. proper behavior is re-enabled when the system is rebooted.
  • 조치
    Product to be modified

Device

Philips MobileDiagnost wDR1 and 2, resistive arrestor strap
  • 모델명 / 제조번호(시리얼번호)
    Model: Models: wDR1 and wDR2, Affected: All MobileDiagnost wDR 1 with serial number lower than 15000005 and all MobileDiagnost wDR 2 with serial number lower than 15100050
  • Manufacturer
    Philips Medical Systems DMC GmbH

Manufacturer

Philips Medical Systems DMC GmbH
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA