BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

    Recall: Z-0522-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0522-2018
    Event ID
    79004
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    November 1, 2017
    Classification Date
    February 4, 2018
    Termination Date
    August 14, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

    Reason

    One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.

    Code Info

    Ingenuity TF PET/CT Model # 882442

    Distribution

    One domestic and 1 foreign consignee ( Spain)

    Quantity

    2