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U.S. Department of Health and Human Services

Class 2 Device Recall Case Cardiac Assessment System and CardioSoft Cardiac Testing System

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  Class 2 Device Recall Case Cardiac Assessment System and CardioSoft Cardiac Testing System see related information
Date Initiated by Firm April 19, 2021
Create Date June 22, 2021
Recall Status1 Completed
Recall Number Z-1927-2021
Recall Event ID 87844
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Code Information CASE and CardioSoft - v6.6x, v6.7x and v7.0
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 11,295 devices (5,637 US; 5,658 OUS)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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