Events

Device Recall RadSuite (by Merge Healthcare) 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
    75267
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0614-2017
  • 사례 시작날짜
    2016-07-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149859
  • 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
    It was reported by a customer that radsuite images are not appearing as readable images. this product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray).
  • 조치
    Merge sent an Urgent Medical Device Recall letter dated October 19, 2016,(Recall #2016-075) to all affected customers. Initially, before it was considered a recall, the firm provided customers with a software upgrade to fix the issue. The letter described the Product, Issue, Potential Harm, Containment by the Customer/User, Action by Merge and Actions by Customers. Requested consignees to complete and return the response form. For questions email recall@merge.com. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 262-367-0700.

Device

Device Recall RadSuite (by Merge Healthcare)
  • 모델명 / 제조번호(시리얼번호)
    RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.
  • 제품 설명
    Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. || Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of thirdparty electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data || The application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2D and reconstructed 3D radiological images using Webenabled viewers over both local and wide area networks. The application provides workflow integration capabilities for health care enterprises, wherein: || ¿ Radiologists can view, annotate, and tag studies as diagnostically Read. || ¿ Referring physicians can view patient images and radiologists annotations. || ¿ Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.