BEUDAMED
    FDA Enforcement Class II 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 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2271-2015
    Event ID
    71592
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    June 22, 2015
    Classification Date
    July 27, 2015
    Termination Date
    May 5, 2017
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    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.

    Code Info

    Catalog Number(s): 8607300

    Distribution

    US Nationwide Distribution

    Quantity

    373