BEUDAMED
    FDA Enforcement Class II Terminated

    Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

    Recall: Z-2300-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2300-2016
    Event ID
    64758
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ge Healthcare It
    Voluntary / Mandated
    N/A
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    February 18, 2013
    Classification Date
    July 28, 2016
    Termination Date
    December 13, 2017
    Address
    540 W Northwest Hwy, N/A, Barrington, IL, 60010-3051, United States

    Description

    Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

    Reason

    A software defect was discovered that causes images to be out of context with clinical information.

    Code Info

    Imagecast PACS 3.5.69, 3.5.86, 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.

    Distribution

    US Nationwide Distribution.

    Quantity

    13