Events

DigitalDiagnost Release 3.1.x 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-00848-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-07-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00848-1
  • 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 healthcare has identified a firmware anomaly inside the detector (4343rc) that can cause the detector to appear ready for acquisition at very short time intervals while it actually is not, resulting in incorrectly acquired x-ray images. a retake of the image is necessary if the captured corrupt image is clinically unusable, leading to additional exposure for the patient.
  • 조치
    Philips is requesting that users: -Read the supplied notice. -Distribute the supplied notice to all users of the device in your facility. -Complete the response form and return it to Philips via fax/email within 3 business days as per the instructions in the customer letter. Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented. Should users need to communicate with Philips with regard to this matter, reference Field Change Order 71200170.

Device

DigitalDiagnost Release 3.1.x

Manufacturer

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