Recall Z-2657-2017— CardioTek BV
Class II · Completed
Class II FDA medical device recall by CardioTek BV, initiated 2017-04-13. It names 2 FDA 510(k) clearances: K161245, K134044. Product: 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.. Reason: Software bug which allows parameters to be changed unintentionally during use..
- Recalling firm
- CardioTek BV
- Classification
- Class II
- Status
- Completed
- Initiated
- 2017-04-13
- Firm location
- Maastricht-Airport, N/A, Netherlands
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Software bug which allows parameters to be changed unintentionally during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.