FDAApril 13, 2017device
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 an...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software bug which allows parameters to be changed unintentionally during use.
What to do
FDA enforcement status: Completed
Brands named
cardiotek bvcardiotek
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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