BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems

    Recall: Z-2491-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2491-2015
    Event ID
    71882
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    July 23, 2015
    Classification Date
    August 31, 2015
    Termination Date
    June 26, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems

    Reason

    Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.

    Code Info

    M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.

    Distribution

    Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.

    Quantity

    11