BEUDAMED
    FDA Recall Terminated

    Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.

    Recall: Z-0138-2010 · Initiated April 16, 2009

    Recall

    Recall Number
    Z-0138-2010
    Event Number
    52056
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 16, 2009
    Posted
    November 9, 2009
    Terminated
    December 3, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.

    Reason

    Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra

    Action

    Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

    Distribution

    Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.

    Quantity

    15 AND 46 UNLOCATED