BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

    Recall: Z-1659-2010 · Initiated March 24, 2010

    Recall

    Recall Number
    Z-1659-2010
    Event Number
    55445
    Firm
    Ge Healthcare, Llc
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 24, 2010
    Posted
    May 26, 2010
    Terminated
    May 21, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

    Reason

    A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios that will cause the next exam to fail and the inability to recall acquired sequences.

    Action

    Consignees were sent on 3/24/10, a GE Healthcare " Urgent Medical Device Correction" letter dated March 23, 2010. The letter included the Safety Issue, Affected Product Details, Product Correction and Contact Information.

    Distribution

    Worldwide distribution: USA, Puerto Rico, VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, PROVINCE OF CHINA, SWEDEN, SPAIN, RUSSIAN FEDERATION, ROMANIA, POLAND, PHILIPPINES, NORWAY, NETHERLANDS, MOROCCO, REPUBLIC OF KOREA, KAZAKSTAN, JAPAN, ITALY, ISLAMIC REPUBLIC OF IRAN, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ARGENTINA.

    Quantity

    28