Events

Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD) 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-2018-RN-00233-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00233-1
  • 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
    Philips has identified that there may be an issue with acquisition if the addonics mass storage device (msd) provided with the system is connected to the console and powered on during an acquisition.Following a period of inactivity, the addonics msd may cause the acquisition console to become unresponsive. this may prevent an acquisition from proceeding resulting in a potential re-scan being required.
  • 조치
    Philips is advising users to not view studies or access data on the Addonics MSD while a patient is being scanned. If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable. It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off. Philips will be providing an updated Mass Storage Device to all affected customer to correct the issue.

Device

Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)
  • 모델명 / 제조번호(시리얼번호)
    Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)PET/CT System Model Number: 882442MSD Serial Number: 2090ARTG Number: 292543(Philips Electronics Australia - Combination diagnostic imaging system, PET/CT)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA