BEUDAMED
    FDA Recall Terminated

    KION Anesthesia System.

    Recall: Z-0710-05 · Initiated January 11, 2005

    Recall

    Recall Number
    Z-0710-05
    Event Number
    31054
    Firm
    Maquet Inc
    FEI Number
    3008355164
    Product Code
    BZR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 11, 2005
    Posted
    April 14, 2005
    Terminated
    June 16, 2005
    Address
    1140 Route 22 East, Bridgewater, NJ, 08807-2912

    Description

    KION Anesthesia System.

    Reason

    Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.

    Action

    MCC has assigned an internal task team to manage plan and perform the correction ofthe installed base of KION (intended for clinical use) in US. Updates started on January 11, 2005.

    Distribution

    The systems were distributed to hospitals throughout the nation.

    Quantity

    40