BEUDAMED
    FDA Recall Terminated

    Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.

    Recall: Z-0571-05 · Initiated January 3, 2005

    Recall

    Recall Number
    Z-0571-05
    Event Number
    30765
    Firm
    Maquet Inc
    FEI Number
    3008355164
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 3, 2005
    Posted
    March 8, 2005
    Terminated
    September 8, 2005
    Address
    1140 Route 22 East, Bridgewater, NJ, 08807-2912

    Description

    Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.

    Reason

    Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

    Action

    Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals.

    Distribution

    The ventilators were distributed to hospitals nationwide. There are 33 VA Medical Center and DOD hospitals nationwide.

    Quantity

    7920 units