Home / Recalls / CardioTek BV / Z-2657-2017

Z-2657-2017 Class II

Recalled by CardioTek BV — Maastricht-Airport, N/A

Recall Details

Product Type: Devices
Report Date: July 12, 2017
Initiation Date: April 13, 2017
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8 units US

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) to states of: CA, IL, OH, and MN; and countries of: Albania, Algeria, Argentina, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Czech Rep, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Monaco, Morocco, Netherlands, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Rep. Dominicana, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad & Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.

Code Information

All EP-Tracer -FSCA-identifier (2017-04-06)