BEUDAMED
    FDA Recall Terminated

    GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. General Electric, Waukesha, WI Indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

    Recall: Z-1399-2012 · Initiated December 23, 2011

    Recall

    Recall Number
    Z-1399-2012
    Event Number
    61553
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 23, 2011
    Posted
    April 24, 2012
    Terminated
    January 16, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. General Electric, Waukesha, WI Indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

    Reason

    GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product, related to the light field to x-ray field edge alignment.

    Action

    GE Healthcare will issue an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect and related hazards, along with the safety instructions, affected product, and product correction GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with an approved plan, the details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the external tube port on the source assembly to address the issue. Questions or concerns can be directed to the Call Center at 800-437-1171 or your local GE Healthcare Service Representative.

    Distribution

    USA (nationwide)

    Quantity

    130 installed in US