The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2657-2017·Announced 2017-07-12

CardioTek EP-TRACER Software Recalled for Unintentional Parameter Changes

CardioTek BV is recalling EP-TRACER Software V1.x and V2.0 due to a bug that allows parameters to be changed unintentionally during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects are rated as Severe (4).

Plain-English summary

CardioTek BV is recalling 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 incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

The recall is due to a software bug which allows parameters to be changed unintentionally during use. The agency has classified this recall as Class II.

The recall affects 8 units in the United States, distributed nationwide to the states of California, Illinois, Ohio, and Minnesota. The product was also distributed worldwide to numerous countries including Albania, Algeria, Argentina, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, 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, Dominican Republic, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad & Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.

The recalled product

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…
Manufacturer
CardioTek BV
Category
Medical Device — Electrophysiology Software
Hazard
Affected units
8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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