BEUDAMED
    FDA Recall Terminated

    Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN

    Recall: Z-0273-05 · Initiated August 24, 2004

    Recall

    Recall Number
    Z-0273-05
    Event Number
    30420
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 24, 2004
    Posted
    December 2, 2004
    Terminated
    September 2, 2005
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN

    Reason

    Software defect causes patient identification number to be truncated.

    Action

    Firm issued a letter notifying users of systems that when transferring image data to a DICOM server for any patient born on January 1, to verify that the Patient ID is correct on the DICOM server after the transfer. Firm will modify the software by January 2005.

    Distribution

    Nationwide.

    Quantity

    39 units