BEUDAMED
    FDA Enforcement Class II 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 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0532-2014
    Event ID
    66064
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trans American Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2014
    Initiation Date
    August 22, 2013
    Classification Date
    January 3, 2014
    Termination Date
    December 29, 2015
    Address
    965 W 325 N, Lindon, UT, 84042, United States

    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.

    Code Info

    Serial numbers NS 10324 through NS 10392

    Distribution

    US Distribution: including states of: WA and UT.

    Quantity

    68