BEUDAMED
    FDA Recall Terminated

    Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.

    Recall: Z-2271-2015 · Initiated June 22, 2015

    Recall

    Recall Number
    Z-2271-2015
    Event Number
    71592
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 22, 2015
    Posted
    July 27, 2015
    Terminated
    May 5, 2017
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.

    Reason

    the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI.

    Action

    Draeger Medical sent an Urgent Medical Device Recall Letter, dated June 2015, and Instructions for Use Supplement (one supplement for each Fabius MRI Anesthesia Machine at the facility) to end users. The letter identified the affected product, problem and actions to be taken. For questions regarding the recall letter contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of the Drger Fabius MRI anesthesia machine contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).

    Distribution

    US Nationwide Distribution

    Quantity

    373