Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is Recalled by CardioTek BV Due to Software bug which allows parameters to be changed...
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 CardioTek BV directly.
Affected Products
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Quantity: 8 units US
Why Was This Recalled?
Software bug which allows parameters to be changed unintentionally during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CardioTek BV
CardioTek BV has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report