BEUDAMED
    FDA Recall Terminated

    DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G)

    Recall: Z-0049-2007 · Initiated October 3, 2006

    Recall

    Recall Number
    Z-0049-2007
    Event Number
    36478
    Firm
    Del Medical Systems Group
    FEI Number
    1418964
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 3, 2006
    Posted
    October 19, 2006
    Terminated
    January 24, 2008
    Address
    11550 West King Street, Franklin Park, IL, 60131-1330

    Description

    DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G)

    Reason

    The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator.

    Action

    Del Medical sent Field Correction Recall letters dated 10/3/06 to the direct accounts, informing them of the potential for the shoulder bolt in the yoke assembly to come loose. If the shoulder bolt comes loose, the tube head 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 and Thailand

    Quantity

    53 units