BEUDAMED
    FDA Recall Terminated

    Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.

    Recall: Z-1437-2010 · Initiated April 2, 2007

    Recall

    Recall Number
    Z-1437-2010
    Event Number
    55252
    Firm
    Diopsys, Inc.
    FEI Number
    3004174467
    Product Code
    GWE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 2, 2007
    Posted
    April 26, 2010
    Terminated
    April 27, 2010
    Address
    16 Chapin Rd, Suite 911, Pine Brook, NJ, 07058

    Description

    Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.

    Reason

    The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007.

    Action

    Field Service personnel were sent an e-mail notification on 4/2/2007 which included a TZedit file to be downloaded. E-mails instructed reps to install the patch on their customers devices immediately. Field correction was completed 7/31/2007.

    Distribution

    Nationwide distribution.

    Quantity

    175 units