BEUDAMED
    FDA Enforcement Class II Terminated

    Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

    Recall: Z-0233-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0233-2014
    Event ID
    66306
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    September 16, 2013
    Classification Date
    November 13, 2013
    Termination Date
    December 21, 2015
    Address
    150 Verona St, Rochester, NY, 14608-1733, United States

    Description

    Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

    Reason

    Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

    Code Info

    Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 8891640

    Distribution

    Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.