BEUDAMED
    FDA Recall Terminated

    Electrophysiology Imaging System

    Recall: Z-1525-05 · Initiated April 28, 2005

    Recall

    Recall Number
    Z-1525-05
    Event Number
    31930
    Firm
    Fischer Imaging Corporation
    FEI Number
    1418957
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2005
    Posted
    September 9, 2005
    Terminated
    March 13, 2012
    Address
    12300 Grant St, Denver, CO, 80241-3120

    Description

    Electrophysiology Imaging System

    Reason

    Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.

    Action

    Consignees were notified by certified letter on 04/27/2005.

    Distribution

    Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.

    Quantity

    51 units