BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance iCT Computed Tomography X-ray system

    Recall: Z-1695-2015 · Reported June 10, 2015

    Enforcement

    Recall Number
    Z-1695-2015
    Event ID
    71231
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2015
    Initiation Date
    April 13, 2015
    Classification Date
    May 29, 2015
    Termination Date
    October 1, 2015
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance iCT Computed Tomography X-ray system

    Reason

    A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.

    Code Info

    Model# 728306; Serial #'s: 85019 & 85023.

    Distribution

    Internationally to the countries of China and Norway.

    Quantity

    2