Events

Rappel de Device Recall RadSuite (by Merge Healthcare)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Merge Healthcare, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75267
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0614-2017
  • Date de mise en oeuvre de l'événement
    2016-07-14
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149859
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, image processing, radiological - Product Code LLZ
  • Cause
    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).
  • Action
    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)
  • Modèle / numéro de série
    RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.
  • Description du dispositif
    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.