BEUDAMED
    FDA Enforcement Class II Terminated

    IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.

    Recall: Z-2267-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2267-2014
    Event ID
    68719
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intelerad Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    July 3, 2014
    Classification Date
    August 19, 2014
    Termination Date
    January 13, 2016
    Address
    895 Rue De La Gauchetiere O, Montreal, N/A, Canada

    Description

    IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.

    Reason

    In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.

    Code Info

    software versions 3-8-1 to 4-9-1

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.

    Quantity

    230