BEUDAMED
    FDA Recall Terminated

    Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143. The indications for use are routine MR imaging.

    Recall: Z-1938-2009 · Initiated December 29, 2008

    Recall

    Recall Number
    Z-1938-2009
    Event Number
    51281
    Firm
    Quality Electrodynamics Llc
    FEI Number
    3007350713
    Product Code
    MOS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 29, 2008
    Posted
    September 10, 2009
    Terminated
    April 25, 2012
    Address
    777 Beta Dr, Cleveland, OH, 44143-2336

    Description

    Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143. The indications for use are routine MR imaging.

    Reason

    The firm received a complaint indicating that the mirror is high risk and could drop on a patient.

    Action

    Quality Electrodynamics, LLC notified Customers via email beginning December 29, 2008 requesting the affected device be returned to the firm for improvement. For further information, contact Quality Electrodynamics, LLC at 1-440-484-2228.

    Distribution

    Nationwide Distribution: IL and OH.

    Quantity

    5 units