Lower riskMedical device recall · FDA · Published April 19, 2021
GE Healthcare Cardiac Systems: Patient Report Mix-Up Risk
GE Healthcare recalls cardiac assessment software versions v6.6x, v6.7x, v7.0 due to risk of patient test reports appearing in incorrect records. Affected users should contact GE for details.
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.
Take action
Contact the company
📍Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
“GE Healthcare Cardiac Systems: Patient Report Mix-Up Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62768-ge-healthcare-cardiac-systems-patient-report-mix-up-risk. Based on FDA recall #Z-1927-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1927-2021%22&limit=1).
GE Healthcare LLC recalled Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG applications due to a hazard where one patient's pdf test report may appear in a different patient's record, according to the FDA. The agency announced the Class II recall on April 19, 2021.
How to tell if you have it
Brand: GE Healthcare
Products: Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Versions: CASE and CardioSoft - v6.6x, v6.7x and v7.0
Quantity: 11,295 devices (5,637 US; 5,658 OUS)
Distribution: Worldwide distribution including US Nationwide, 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
The hazard
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, according to the FDA.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since Oct. 4, 2017. Other recent recalls include GE Healthcare SIGNA Premier MRI Scanners May Have Steel Fittings Risking Injury (Feb. 27, 2026), GE Centricity Universal Viewer 6.0/7.0/8.0: Inaccurate Distance Measurements (July 15, 2022), and GE Healthcare SIGNA Premier MRI Scanner Recall: Risk of Hearing Loss from Acoustic Noise (June 24, 2022). Similar recent recalls include GE Medical Systems ECG Systems Software Error Risks Patient Data Mix-Up (April 21, 2026), GE Healthcare Workflow Core Services V8 Recall: Patient Data Mismatch Risk (July 31, 2026), and GE Healthcare Enterprise Archive V8 Software Recall: Patient Data Mismatch Risk (July 31, 2026).
How to tell if you have this one
Check if you have the Case Cardiac Assessment System or CardioSoft Diagnostic System software versions v6.6x, v6.7x, or v7.0. The software is used for cardiac stress testing and ECGs in healthcare settings.
Brand
GE Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact GE Healthcare
Reach out to GE Healthcare for specific guidance on the affected software versions and next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 4.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1927-2021 (April 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1927-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.