BEUDAMED
    FDA Enforcement Class II Terminated

    728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

    Recall: Z-2314-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2314-2021
    Event ID
    88336
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    June 8, 2021
    Classification Date
    August 18, 2021
    Termination Date
    August 10, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

    Reason

    When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

    Code Info

    S/N UDI: 87013 (01)00884838059474(21)87013 87008 (01)00884838059474(21)87008 87011 (01)00884838059474(21)87011 Software Version 4.1.10 SynchRight Option

    Distribution

    US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

    Quantity

    3 units