Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic Recalled by GE Healthcare, LLC Due to If a certain sequence of events occur, the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.
Affected Products
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Quantity: 11,295 devices (5,637 US; 5,658 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE Healthcare, LLC
GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report