BEUDAMED
    FDA Recall Terminated

    Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number

    Recall: Z-0532-2014 · Initiated August 22, 2013

    Recall

    Recall Number
    Z-0532-2014
    Event Number
    66064
    Firm
    Trans American Medical, Inc.
    FEI Number
    1000219700
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 22, 2013
    Posted
    January 3, 2014
    Terminated
    December 29, 2015
    Address
    965 W 325 N, Lindon, UT, 84042

    Description

    Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number

    Reason

    TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing uncommanded X-ray.

    Action

    TransAmerican Medical sent an Urgent Medical Device Correction letter dated August 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all potential users in their facility are made aware of the safety notification and the recommended actions. If the customers system does produce an uncommanded X-ray, turn the system off immediately. Remove the Spectre Wireless Footswitch and receiver and reinstall the standard OEM footswitch. Follow proper shutdown/system reboot instructions as indicated in the system operator's manual. Customers will be contacted to make arrangements for replacement of their TMi Spectre Wireless Footswitch at no charge. Customers will be provided a new TMI Spectre Wireless Footswitch and instructions on how to return the affected footswitch. Customers with questions were instructed to call 801-796-7335, ext 203.

    Distribution

    US Distribution: including states of: WA and UT.

    Quantity

    68