BEUDAMED
    FDA Recall Terminated

    Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system

    Recall: Z-2175-2018 · Initiated March 30, 2018

    Recall

    Recall Number
    Z-2175-2018
    Event Number
    80094
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2018
    Terminated
    April 14, 2020
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system

    Reason

    The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.

    Action

    Urgent Field Safety Notices dated 3/28/18 were distributed to customers. The letters instructed customers to perform the following actions: Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. As outlined in the Instructions for Use, always monitor the patient during all movements (manual or motorized) of the patient support. If you recognize an impending collision with the back shelter wall, halt the motion or activate the system E-stop. Mandatory Field Change Order (FCO) 72800686 which will add additional warning labels specific to this issue to the system. The FCO will be implemented free of charge.

    Distribution

    Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.

    Quantity

    2