Events

Device Recall Merge OfficePACS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merge Healthcare, 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
    74522
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2144-2016
  • 사례 시작날짜
    2016-01-30
  • 사례 출판 날짜
    2016-07-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147824
  • 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
    System, image processing, radiological - Product Code LLZ
  • 원인
    Potential data loss occurs as a result of the software archiving not working properly.
  • 조치
    Merge Healthcare sent an Urgent Medical Device Recall letter dated January 26, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to provide a copy of the notification to all users. For additional questions customers were advised to call Merge Customer Service at (87) 741-5369. For questions regarding this recall call 262-367-0700.

Device

Device Recall Merge OfficePACS
  • 모델명 / 제조번호(시리얼번호)
    Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.
  • 제품 설명
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. || OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.