BEUDAMED
    FDA Recall Terminated

    MediSpectra Luma Cervical Imaging System Model Number: 3-02600

    Recall: Z-0988-2007 · Initiated May 15, 2007

    Recall

    Recall Number
    Z-0988-2007
    Event Number
    37954
    Firm
    Medispectra Inc.
    FEI Number
    3002634893
    Product Code
    MWM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 15, 2007
    Posted
    July 3, 2007
    Terminated
    July 9, 2007
    Address
    45 Hartwell Ave, Lexington, MA, 02421-3102

    Description

    MediSpectra Luma Cervical Imaging System Model Number: 3-02600

    Reason

    Power supply may fail and render the unit inoperable.

    Action

    MediSpectra notified users by telephone on 5/15/07 and follow-up letter. Users are requested to select a date for field servce to replace the power supply.

    Distribution

    AZ, CA, FL, & NY.

    Quantity

    8 units