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CardioTek BV

2 recalls •
🏥 Medical Devices
• Categories: Other Medical Devices, Diagnostic Equipment

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.

Class I - Dangerous

Software bug which allows parameters to be changed unintentionally during use.

Apr 13, 2017 Diagnostic Equipment Nationwide View Details →