BEUDAMED
    FDA Recall Terminated

    Bloom DTU-215-B Programmable Stimulator

    Recall: Z-0713-05 · Initiated January 13, 2005

    Recall

    Recall Number
    Z-0713-05
    Event Number
    30986
    Firm
    Fischer Imaging Corporation
    FEI Number
    1418957
    Product Code
    JOQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 13, 2005
    Posted
    April 19, 2005
    Terminated
    March 13, 2012
    Address
    12300 Grant St, Denver, CO, 80241-3120

    Description

    Bloom DTU-215-B Programmable Stimulator

    Reason

    Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.

    Action

    Customers were notified by letter on 01/13/05.

    Distribution

    Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.

    Quantity

    712 units