BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.

    Recall: Z-1942-2013 · Initiated August 7, 2012

    Recall

    Recall Number
    Z-1942-2013
    Event Number
    64992
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 7, 2012
    Posted
    August 9, 2013
    Terminated
    February 4, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.

    Reason

    GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance.

    Action

    GE Healthcare recall strategy was to update all of the affected Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems that were distributed. At this time ( 2/14/2013), deployment of this recall is considered complete. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2198 or email [email protected]

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: Albania, Australia, Bahrain, Belgium, Canada, Chile, Czech Republic, Dominican Republic, France, Germany, Great Britain, Honduras, Hungary, Ireland, Israel, Italy, Japan, Korea, Kuwait, Netherlands, Nigeria, Norway, Romania, Saudi Arabia, Spain, United Arab Emirates and Venezuela.

    Quantity

    458 (306 US; 152 OUS)