BEUDAMED
    FDA Recall Terminated

    Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.

    Recall: Z-1315-2008 · Initiated February 5, 2008

    Recall

    Recall Number
    Z-1315-2008
    Event Number
    46806
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 5, 2008
    Posted
    July 16, 2008
    Terminated
    September 9, 2008
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.

    Reason

    Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.

    Action

    Consignees were notified by an Urgent Medical Device Recall letter sent on 2/7/08. The letter informed users that the recalling firm will contact them to schedule appointments to inspect any potentially affected machines. The letter instructed users to continue using the machines, before the inspection, making sure to carefully follow the warnings in the instruction manual. If a caster on the machine appears unstable before the inspection is conducted, users were advised to contact the recalling firm. For additional information, contact 1-800-543-5047.

    Distribution

    Nationwide Distribution.

    Quantity

    196 UNITS