BEUDAMED
    FDA Enforcement Class I Terminated

    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.

    Recall: Z-0216-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0216-2020
    Event ID
    84009
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 13, 2019
    Initiation Date
    September 19, 2019
    Classification Date
    November 1, 2019
    Termination Date
    April 5, 2021
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.

    Reason

    An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

    Code Info

    System Code: 889456 System Serial Number: 24

    Distribution

    Nationwide Distribution.

    Quantity

    1167 in total