BEUDAMED
    FDA Recall Terminated

    Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.

    Recall: Z-0089-06 · Initiated October 7, 2005

    Recall

    Recall Number
    Z-0089-06
    Event Number
    33816
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 7, 2005
    Posted
    October 25, 2005
    Terminated
    November 29, 2007
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.

    Reason

    overhead system can fall due to the failure of a retaining ring.

    Action

    The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/7/05 to all customers. The notice informs customers of the problem and cautions anyone to be under the system when in use. The notice also informs the customer that a firm representative will schedule a time to perform the upgrade. On 10/13/05, the recalling firm also issued a notification to scanner manufacturers alerting them of the problem.

    Distribution

    The product was shipped to medical facilities nationwide. The product was also shipped to Austria, Belgium, Chile, Czech, Denmark, Spain, Finland, France, Great Britain, Ireland, Israel, Italy, Netherlands, Norway, Sweden, Austrailia, Kuwait, Saudia Arabia, Canada, China, Hong Kong, India, Korea, Singapore, Taiwan, Brazil, Columbia, Cuba, Mexico, and Japan.

    Quantity

    2080 units