Philips SENSE Body Coil 1.5T (used with ACS NT, Intera 1.5T, and Achieve 1.5T MR 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
    18767
  • 사례 시작날짜
    2015-07-03
  • 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
    The instructions for use state how (and how not) to position the sense body coil 1.5t and its cables in relation to the patient and mr bore in order to avoid a hazardous situation. when these instructions are not followed during an examination, the positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to rf coupling to the quadrature body coil (qbc).
  • 조치
    Product to be modified

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: 4522 131 5575x, 4522 132 1985x. 4522 132 7619x, 4598 000 5187x, 4598 000 5189x, 4598 003 590511 (where x can be a number from 1 to 9), Affected: All lots
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    NZMMDSA