BEUDAMED
    FDA Recall Terminated

    Exradin A12 Ionization Chamber

    Recall: Z-0952-03 · Initiated May 28, 2003

    Recall

    Recall Number
    Z-0952-03
    Event Number
    26445
    Firm
    Standard Imaging Inc.
    FEI Number
    1000115748
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 28, 2003
    Posted
    June 27, 2003
    Terminated
    July 2, 2004
    Address
    7601 Murphy Rd, Middleton, WI, 53562

    Description

    Exradin A12 Ionization Chamber

    Reason

    Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.

    Action

    The consignees were telephoned on May 28, 2003 and informed of the problem and recall, and sent a recall letter, dated May 28, 2003, requesting the return of the product.

    Distribution

    The product was shipped to 24 hospitals located nationwide in the United States.

    Quantity

    25 units