BEUDAMED
    FDA Recall Terminated

    GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option.

    Recall: Z-1517-2008 · Initiated October 21, 2007

    Recall

    Recall Number
    Z-1517-2008
    Event Number
    45538
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 21, 2007
    Posted
    September 29, 2008
    Terminated
    December 17, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option.

    Reason

    Incorrect dose data: GE Healthcare has found that after 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option) may be underestimated by up to 50%. In order to avoid this issue, it is necessary to perform a system reset or reboot every day. GE Healthcare is working on a c

    Action

    GE sent all customers with affected units a letter on 11/15/07 titled Urgent Medical Device Correction. In the US this was sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX overnight Delivery). The letter was sent to 3 titles within the affected accounts; Hospital Administrator, Manager of Radiology/Cardiology and Radiologist/ Cardiologist. A correction letter identified a short term recommendation to perform a system reset or reboot every day and stated that a software correction will be installed at their site at no cost.

    Distribution

    Worldwide Distribution: USA, Argentina, Australia, Canada, China, Germany, Japan, Mexico and Russia.

    Quantity

    146 total