Z-1927-2021Class II

Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing...

Name: Z-1927-2021 Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing...
Creator: GE Healthcare, LLC
Published: 2021-04-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-04-19 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application on 2021-04-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1927-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-19
Posted: 2021-06-22
Terminated: 2026-01-14
Recalling firm: GE Healthcare
Product: Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: CASE and CardioSoft - v6.6x, v6.7x and v7.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1927-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1927-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-22

Product code DQK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)