FDAFDA · Food and drugs·Recall number Z-2657-2017
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.
Published July 12, 2017 · Recall initiated: April 13, 2017
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software bug which allows parameters to be changed unintentionally during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CardioTek BV
- Distributor
- 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.
- Lot
- All EP-Tracer -FSCA-identifier (2017-04-06)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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