BEUDAMED
    FDA Recall Terminated

    Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330 Konica Minolta Medical & Graphic, Inc. No. 26-2, Nishishinjuku 1-chrome, Shinjuku-ku, Tokoyo 163-0512, Japan

    Recall: Z-0220-2007 · Initiated October 6, 2006

    Recall

    Recall Number
    Z-0220-2007
    Event Number
    36658
    Firm
    Konica Minolta Medical Imaging USA, Inc.
    FEI Number
    2241281
    Product Code
    LMD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2006
    Posted
    November 28, 2006
    Terminated
    August 1, 2008
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657

    Description

    Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330 Konica Minolta Medical & Graphic, Inc. No. 26-2, Nishishinjuku 1-chrome, Shinjuku-ku, Tokoyo 163-0512, Japan

    Reason

    The power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit.

    Action

    Letters were sent to all customers by first class US mail, certified receipt requested on 10/10/2006. Customers were also notified by fax and e-mail and a phone call on the same day.

    Distribution

    Nationwide to imaging centers, hospitals and clinics.

    Quantity

    91 units