Philips Allura Xper FD and Allura Clarity x-ray systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems Nederland BV 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
    19424
  • 사례 시작날짜
    2015-11-23
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 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
    In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required in 21cfr1020.32 (h)(2)(ii) and iec 60601-2-54, clause 203.6.2.1.C. no injuries attributed to the problem are reported.
  • 조치
    Software to be upgraded

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: 722003, 722005, 722006, 722008, 722010, 722012, 722013, 722015, 722023, 722026, 722028, 722035, 722058, Affected: , Software version: All (upgrades to) Allura XPER or AlluraClarity with software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    NZMMDSA