BEUDAMED
    FDA Recall Terminated

    GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver subsystem; -A computer platform running the Apex Pro Telemetry Application; -A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)

    Recall: Z-0055-2007 · Initiated August 4, 2006

    Recall

    Recall Number
    Z-0055-2007
    Event Number
    36034
    Firm
    Ge Healthcare
    FEI Number
    3005860720
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 4, 2006
    Posted
    October 20, 2006
    Terminated
    July 3, 2012
    Address
    9900 W Innovation Dr, Wauwatosa, WI, 53226-4856

    Description

    GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver subsystem; -A computer platform running the Apex Pro Telemetry Application; -A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)

    Reason

    When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC (Clinical Information Center) does not occur.

    Action

    An Urgent Medical Device Correction letter dated August 04, 2006 was sent to customers with affected devices. The letter described the issue affecting devices containing software versions v3.8 and earlier, provides short term recommendations and a long term solution of updating the software.

    Distribution

    Worldwide-USA and Puerto Rico and countries of ,Australia, Belgium, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Guam, Honduras, Hong Kong, Hunary, India, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerlant, Syria, Taiwan, Thailand, Tunisia, and Venezuela.

    Quantity

    5,203