BEUDAMED
    FDA Enforcement Class II Terminated

    Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others

    Recall: Z-1495-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1495-2014
    Event ID
    67868
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    April 2, 2014
    Classification Date
    April 24, 2014
    Termination Date
    June 16, 2016
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others

    Reason

    Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations

    Code Info

    Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1

    Distribution

    Worldwide Distribution - US Distribution including Puerto Rico and the states of CA, FL, IL, NJ, OK and WA., and the countries of : Argentina Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Bosnia, Brazil, Bulgaria, Chile, China, Egypt, Ethiopia, France, Germany, Ghana, Greece, Guinea, India, Iraq, Israel, Italy, Latvia, Libya, Lithuania, Malawi, Malta, Mexico, Mozambique, Nepal, New Zealand, Papua, New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Solomon Islands, South Africa, Spain, Thailand, Turkey, United Arab Emirates and United Kingdom.

    Quantity

    373 units