Events

Philips EPIQ 5 Ultrasound System without pediatic cardiology option 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Ultrasound 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
    18510
  • 사례 시작날짜
    2015-05-14
  • 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 epiq 5 ultrasound system is set up to 'metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's body surface area (bsa)., when using both height and weight to calculate the bsa, which is the usual practice for patients above the age of 2 years, the result may be too high by a factor of about 10, an error that would be readily identified by the user.
  • 조치
    Software to be upgraded

Device

Philips EPIQ 5 Ultrasound System without pediatic cardiology option
  • 모델명 / 제조번호(시리얼번호)
    Model: EPIQ 5, Affected: , Software version: 1.3.2 or lower without Pediatric Cardiology option
  • Manufacturer
    Philips Ultrasound

Manufacturer

Philips Ultrasound
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA