BEUDAMED
    FDA Recall Terminated

    GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

    Recall: Z-1520-2008 · Initiated August 17, 2006

    Recall

    Recall Number
    Z-1520-2008
    Event Number
    48977
    Firm
    Datex Ohmeda, Inc
    FEI Number
    2183066
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 17, 2006
    Posted
    September 30, 2008
    Terminated
    June 9, 2009
    Address
    Po Box 7550, Madison, WI, 53707

    Description

    GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

    Reason

    User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.

    Action

    GE Field Engineers are visiting all affected customers to apply updated software. For assistance contact Datax-Ohmeda, Inc., at 1-608-221-1551.

    Distribution

    within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom

    Quantity

    71