Events

Device Recall Agfa IMPAX Cardiovascular 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGFA Healthcare Corp. 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
    77629
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2652-2017
  • 사례 시작날짜
    2016-12-22
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156955
  • 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
    A customer experienced when using impax cv reporting software, specifically, when building a niv report, the niv cardio report was showing incorrect findings for aneurysm.
  • 조치
    AGFA Healthcare sent an Urgent Field Safety Notice dated December 22, 2016, to all affected consignees. The notice included an acknowledgement fax-back or email indicating that the information was received and understood. The notice informed the consignees of the problem and indicated that they would be contacted by Agfa Service to check the problem and to correct the NIV reporting clinical content. Customers with questions were instructed to call 1-401-330-7433. For questions regarding this recall call 864-421-1984.

Device

Device Recall Agfa IMPAX Cardiovascular
  • 모델명 / 제조번호(시리얼번호)
    Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
  • 제품 설명
    IMPAX Cardiovascular || The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • 제조사 주소
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • 제조사 모회사 (2017)
    Agfa-Gevaert NV
  • Source
    USFDA