Events

Device Recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare Informatics, Inc. 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
    68262
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1646-2014
  • 사례 시작날짜
    2014-05-05
  • 사례 출판 날짜
    2014-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127235
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Medical device data system - Product Code OUG
  • 원인
    When using xiris rio version (8.1.50.0) in conjuncture with isite pacs a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed.
  • 조치
    Philips Healthcare sent an Urgent Field Safety Notice dated May 5, 2014. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised of the synchronization problem and request that a copy of this notification be kept with the equipment instructions for use. The document goes on to outline the affected product, the problems and conditions when it can occur. A photo of the label for easy identity the actions to be taken are provided. Philips is informing users of the issue via the notification and will deploy a software correction to all customers when available. Questions may be directed to Philips reps or Care at 1-866-946-4701 or OneEMSProd@philips.com

Device

Device Recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50
  • 모델명 / 제조번호(시리얼번호)
    Model XIRIS 8.1 version XIRIS 8.1.50.0
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
  • 제품 설명
    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 || XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
  • Manufacturer
    Philips Healthcare Informatics, Inc.

Manufacturer

Philips Healthcare Informatics, Inc.
  • 제조사 주소
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA