BEUDAMED
    FDA Recall Terminated

    Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.

    Recall: Z-0342-2007 · Initiated October 17, 2006

    Recall

    Recall Number
    Z-0342-2007
    Event Number
    36672
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 17, 2006
    Posted
    January 25, 2007
    Terminated
    October 2, 2009
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.

    Reason

    During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician

    Action

    Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.

    Distribution

    Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.

    Quantity

    7,404 Handheld PCs pre-programmed with software.