BEUDAMED
    FDA Recall Terminated

    Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131

    Recall: Z-0816-05 · Initiated March 10, 2005

    Recall

    Recall Number
    Z-0816-05
    Event Number
    31456
    Firm
    Del Medical Systems Group
    FEI Number
    1418964
    Product Code
    IYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2005
    Posted
    May 11, 2005
    Terminated
    November 14, 2005
    Address
    11550 West King Street, Franklin Park, IL, 60131-1330

    Description

    Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131

    Reason

    The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead arm assembly could fall and contact the patient or operator.

    Action

    Del Medical sent Field Correction Recall letters dated 3/10/05 to the direct accounts, informing them of the potential for a defective weld supporting the braket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly could potentially fall and contact the patient or operator. The accounts were requested to locate the affected systems and take them out of service until they are inspected and, if needed, repaired.

    Distribution

    Nationwide, Mexico and Thailand.

    Quantity

    31 stands