Company: CardioTek BV.
Date of Enforcement Report 7/12/2017
Class lI:

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.
Recall Number Z-2657-2017

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

RECALLING FIRM/MANUFACTURER
CardioTek BV, Netherlands on 4/13/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
8 units in US

DISTRIBUTION
Nationwide and internationally

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