BEUDAMED
    FDA Recall Terminated

    GE Healthcare Carescape Patient Data Module

    Recall: Z-0060-2015 · Initiated September 19, 2014

    Recall

    Recall Number
    Z-0060-2015
    Event Number
    69207
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 19, 2014
    Posted
    October 9, 2014
    Terminated
    September 13, 2016
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Carescape Patient Data Module

    Reason

    GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an

    Action

    Consignees were sent on 9/19/2014 a GE Healthcare "Urgent Medical Device Correction" letter Ref# 336107 dated September 18, 2014. The letter was addressed to Director of Biomedical Engineering, Chief of Nursing and Healthcare Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions , Affected Product Details, Product Correction and Contact Information. For questions they can contact Technical Support at 1-800-558-70444 or your local Service Representative.

    Distribution

    Worldwide Distribution: US (nationwide) including DC, PR, Guantanamo except DE, HI, ND, SD & WY; and countries of: SOUTH AFRICA, KOREA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, TRINIDAD TOBAGO, THAILAND, TANZANIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, BRASIL, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, PARAGUAY, OMAN, NEW ZEALAND, NORWAY, NETHERLAND, NEPAL, MYANMAR, MEXICO, MOROCCO, MALDOVA, MAURITIUS, MALAYSIA, LITHUANIA, LEBANON, BAHRAIN, KUWAIT, REPUBLIC OF KOREA, JAPAN, JORDAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUATEMALA, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT,ECUADOR, DENMARK, CECH REPUBLIC, COSTA RICA, COLOMBIA,, CHINA, CANADA, BULGARIA, BELGIUM BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.

    Quantity

    68,452 (39,505 units US, 24,711 units OUS, 4,236 units unidentified/unknown)