BEUDAMED
    FDA Recall Terminated

    Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.

    Recall: Z-1391-05 · Initiated March 30, 2005

    Recall

    Recall Number
    Z-1391-05
    Event Number
    32068
    Firm
    Konica Medical Imaging, Inc.
    FEI Number
    2241281
    Product Code
    LMA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2005
    Posted
    August 13, 2005
    Terminated
    August 31, 2005
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657

    Description

    Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.

    Reason

    One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.

    Action

    The firm contacted all customers of the problem on 4/7/2005.

    Distribution

    These units have been distributed to hospitals and clinics nationwide.

    Quantity

    60