FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
- Recall number
- Z-1927-2021
- Recalling firm
- GE Healthcare, LLC
- Product
- Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
- Status
- Terminated
- Initiated
- 2021-04-19
- Posted
- not on file
- Terminated
- 2026-01-14
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- CASE and CardioSoft - v6.6x, v6.7x and v7.0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28