BEUDAMED
    FDA Recall Terminated

    GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.

    Recall: Z-0725-2014 · Initiated November 7, 2013

    Recall

    Recall Number
    Z-0725-2014
    Event Number
    67136
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 7, 2013
    Posted
    January 11, 2014
    Terminated
    May 6, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.

    Reason

    There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile x-ray system are not properly displayed. If the user continues to attempt to select one of the exams w

    Action

    GE sent an Urgent Medical Device Correction letter, dated 11/7/2013 to consignees. The letter described the issue, identified devices affected and stated that users should pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure that the system did not update and select an incorrect exam. The user may also confirm during the exam that the appropriate patient information was selected via the display on the upper left portion. GE will fix the units with a software fix at no cost.

    Distribution

    Worldwide Distribution-USA (nationwide) including Washington D.C., and Guam and the countries of ALBANIA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA , COLOMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAQ, IRELAND, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, NIGERIA, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.

    Quantity

    1027