BEUDAMED
    FDA Recall Terminated

    EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function.

    Recall: Z-0914-06 · Initiated April 4, 2006

    Recall

    Recall Number
    Z-0914-06
    Event Number
    35206
    Firm
    EP Medsystems
    FEI Number
    2126673
    Product Code
    JOQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 4, 2006
    Posted
    May 31, 2006
    Terminated
    April 24, 2007
    Address
    575 Route 73 North, Bldg D, Cooper Run Executive Park West Berlin, NJ, 08091

    Description

    EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function.

    Reason

    Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system

    Action

    The firm initiated the recall on April 4, 2006 through a notification letter sent to the electrophysiology lab managers at the healthcare institutions and two domestic distributors to which the device has been distributed. The firm used a traceable courier service to deliver notification of the recall.

    Distribution

    Product was shipped to hospitals/users throughout the US. The firm has a Veterans Affair contract number V797P-4650A. Also the firm has shipped the devices to Germany, United Kingdom, Netherlands, Italy, Japan, France, Saudi Arabia, Hong Kong, Syria, Malaysia, Sweden, Armenia, Australia, Canada, Iceland, S. Africa, and Taiwan.

    Quantity

    187 units