BEUDAMED
    FDA Recall Terminated

    Model 4000 Monitor component of the LifeVest Wearable Defibrillator

    Recall: Z-0625-2011 · Initiated September 24, 2010

    Recall

    Recall Number
    Z-0625-2011
    Event Number
    56957
    Firm
    Zoll Lifecor Corporation
    FEI Number
    3008642652
    Product Code
    MVK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2010
    Posted
    December 16, 2010
    Terminated
    July 5, 2012
    Address
    121 Freeport Rd, Pittsburgh, PA, 15238-3411

    Description

    Model 4000 Monitor component of the LifeVest Wearable Defibrillator

    Reason

    The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.

    Action

    Zoll Life Vest contacted patients that are expected to be in the device more than 60 days by letter and phone to arrange replacement monitors. Instructions for the return of the recalled monitor accompany the replacement monitor The firm will also contact the prescribing physician via telephone for long-term use patients to inform the physician of this voluntary recall and to assist in contacting any patients the firm was unable to reach by telephone. Zoll Life Vest can be contacted at 1-800-543-3267 about this recall.

    Distribution

    Nationwide Distribution: Throughout the US. including the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV.

    Quantity

    494 units