BEUDAMED
    FDA Recall Terminated

    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application

    Recall: Z-1927-2021 · Initiated April 19, 2021

    Recall

    Recall Number
    Z-1927-2021
    Event Number
    87844
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 19, 2021
    Terminated
    January 14, 2026
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application

    Reason

    If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.

    Action

    The recalling firm issued letters dated 4/19/2021 beginning 4/19/2021. For systems that are on Windows 8.1 and above, the issue will be corrected through a software patch. For the units running on Microsoft Windows Server 2008-R2, Windows XP, and Windows 7, the letter instructs that the devices are not to be networked on these systems and that a software patch cannot be made available to these systems since the operating systems are not supported by Microsoft. A second cover letter and customer notification were issued dated 5/10/2021 updating the second safety instruction regarding the units running on Microsoft Windows Server 2008-R2, Windows XP, and Windows 7 saying that these systems must be rebooted before manually exporting tests.

    Distribution

    Worldwide distribution - US Nationwide. Government/military distribution was also made, and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Czechia, Denmark, Estonia, Fiji, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Mexico, Moldova, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.

    Quantity

    11,295 devices (5,637 US; 5,658 OUS)