BEUDAMED
    FDA Recall Terminated

    Regius Model 370 Digital Radiography Konica Minolta

    Recall: Z-1481-06 · Initiated July 14, 2006

    Recall

    Recall Number
    Z-1481-06
    Event Number
    36109
    Firm
    Konica Minolta Medical Imaging USA, Inc.
    FEI Number
    2241281
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 14, 2006
    Posted
    August 31, 2006
    Terminated
    September 5, 2006
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657

    Description

    Regius Model 370 Digital Radiography Konica Minolta

    Reason

    A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding it lost his or her balance and almost fell. This problem only occurred in Japan with one system.

    Action

    Konica Minolta USA contacted the site of the sole US user by phone on 7/14/06, followed by e-mail and certified mail/return receipt.

    Distribution

    Texas

    Quantity

    1 in US