BEUDAMED
    FDA Recall Terminated

    SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.

    Recall: Z-2442-2008 · Initiated July 8, 2008

    Recall

    Recall Number
    Z-2442-2008
    Event Number
    49117
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 8, 2008
    Posted
    September 23, 2008
    Terminated
    December 23, 2008
    Address
    1140 US Highway 22, Bridgewater, NJ, 08807-2958

    Description

    SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.

    Reason

    Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.

    Action

    Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.

    Distribution

    Worldwide.

    Quantity

    122 units (SERVO-i and SERVO-s) units in United States