BEUDAMED
    FDA Recall Terminated

    Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN

    Recall: Z-0652-03 · Initiated September 24, 2002

    Recall

    Recall Number
    Z-0652-03
    Event Number
    26111
    Firm
    Sedecal USA, Inc.
    FEI Number
    1000139935
    Product Code
    KPR--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2002
    Posted
    April 25, 2003
    Terminated
    July 29, 2005
    Address
    2910 N. Arlington Heights Rd, Arlington Heights, IL, 60004

    Description

    Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN

    Reason

    Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.

    Action

    Sedecal USA sent end user notification letters dated 9/24/02 to the consignees having the affected Sedecal Stationary X-Ray Systems, informing them that the units do not meet with the U.S. federal performance standards, that the labels are in Spanish and that the labels may not be visible after system installation. Sedecal schedule an appointment to conduct performance tests on the mobile x-ray systems to verify their compliance with the federal performance standard, submit the data to FDA, and place the English labels on the units. Sedecal will reimburse the owners for any out-of-pocket expenses incurred. Sedecal requested the accounts to call 800-920-9525 if they had any questions, and to inform Sedecal if they sold the unit, destroyed the unit or otherwise no longer had the unit in their possession.

    Distribution

    New York, Texas, Florida and Minnesota.

    Quantity

    5 units