BEUDAMED
    FDA Recall Terminated

    GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.

    Recall: Z-0487-2018 · Initiated January 11, 2018

    Recall

    Recall Number
    Z-0487-2018
    Event Number
    78918
    Firm
    GE Medical Systems Information Technologies, Inc.
    FEI Number
    2124823
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    January 11, 2018
    Posted
    January 25, 2018
    Terminated
    July 7, 2021
    Address
    8200 W Tower Ave, Milwaukee, WI, 53223-3219

    Description

    GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.

    Reason

    CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.

    Action

    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and email to its consignees on 01/11/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions and follow the safety instructions. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044 or your local Service Representative.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Algeria, Australia, Austria, Canada, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Norway, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.

    Quantity

    1803 units