Philips Allura Xper X-Ray Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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
    RC-2017-RN-00432-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-05
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Through customer complaints, philips has discovered problem with the detector cooling system for a limited number of allura xper and allura cv20. due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. if this occurs the liquid may drip onto electrical components in the r-cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odour, smoke or fire. to date, philips is not aware of any injuries that may have occurred as a result of this problem.
  • 조치
    Philips is advising users that if a burning odour, smoke or fire is detected coming from the technical room, the main switch should be turned off and system taken out of service immediately. In the event of a hazardous situation, users are requested to adhere to their workplace emergency procedures. Once any hazardous situation has been abated, users are advised to inform their local Philips representative. (Please note: Philips will start inspecting affected systems for leaks and repair as required. In addition as from April 2017, Philips will undertake a free installation of an extended drip tray on affected systems to prevent damage from any future leaks).

Device

  • 모델명 / 제조번호(시리얼번호)
    Philips Allura Xper X-Ray SystemsAllura Xper and Allura CV20 Releases 3 to 8.1 with an installed Laird chillerAllura Xper Release 8.2: only configurations FD10, FD10/10, FD20/10, FD20/20 have a Laird chillerMultiple Product Names and CodesARTG Number: 225815
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA