BEUDAMED
    FDA Recall Terminated

    GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems. GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA

    Recall: Z-1134-2007 · Initiated February 16, 2007

    Recall

    Recall Number
    Z-1134-2007
    Event Number
    37640
    Firm
    General Electric Medical Systems Information Technology
    FEI Number
    2124823
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 16, 2007
    Posted
    August 7, 2007
    Terminated
    December 11, 2011
    Address
    8200 W Tower Ave, Milwaukee, WI, 53223-3219

    Description

    GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems. GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA

    Reason

    GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.

    Action

    Consignees were sent a letter dated 2/16/07. The letter described the product and problem, made recommendations and gave information on software update.

    Distribution

    Worldwide, including USA, Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Pakistan, Panama, Puerto Rico, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Kingdom, and Venezuela.

    Quantity

    832 (409 US and 423 OUS)