BEUDAMED
    FDA Enforcement Class II Terminated

    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.

    Recall: Z-1593-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1593-2016
    Event ID
    73742
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    April 15, 2016
    Classification Date
    May 2, 2016
    Termination Date
    March 16, 2017
    Address
    150 Verona St, Rochester, NY, 14608-1733, United States

    Description

    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.

    Reason

    Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".

    Code Info

    Equipment ID Numbers: US units: 8501-2596, 85018860, 8501-0954, 5241-2596, 5241-2546, 5241-2713, 5296-3447, 52414419, 52414455, 5241-2640, 5241-2716, 54838552, 5483-8502, 8501-4665, 52408158, 85014687, 54839128, 5483-9212, 52412539, 52414661, 52962897, 4745-3986, 5241-2337, 85012262, 8501-5898, 8501-2602, 54838630, 52412670, 5296-3450, 5296-3449, 54838554, 52408157, 54838618, 5241-4547, 54842652, 52420675, 8501-2861, 52414685, 52414751, 5484-3086, 54838598, 52412367, 52414417, 54839211, 54838616, 4745-5991, 52412243, 54842667, 52417149, 52412340; -- Equipment ID Numbers for Foreign Units: Please contact CDRH Recall Group for list of affected Equipment ID Numbers.

    Distribution

    NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia, Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam.

    Quantity

    US: 50 units; Foreign: 2499 units