Z-2657-2017Class II

CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system...

Name: Z-2657-2017 CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system...
Creator: CardioTek BV
Published: 2017-04-13
License: https://open.fda.gov/license/

CardioTek BV / initiated 2017-04-13 / Completed / root cause: software

FDA source

CardioTek BV began a recall of 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... on 2017-04-13. FDA classified it as Class II and gives the reason as "Software bug which allows parameters to be changed unintentionally during use". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-2657-2017
Classification: Class II
Status: Completed
Initiated: 2017-04-13
Posted: 2017-06-30
Recalling firm: CardioTek BV
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 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.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Software bug which allows parameters to be changed unintentionally during use.
Root cause tag: software
FDA root cause: Software design
Action: The Firm, Schwarzer cardiotek, sent an "Urgent Field Safety Notice" dated 4/21/2017 to its consignees. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following: " While backup pacing is active the software must not be operated. " In case of backup pacing disconnect all catheter connection pins and reconnect only the two required for stimulation to the dedicated backup pacing output ports (OUT1 or OUT2). " If the backup pacing parameters were changed by accident quickly switch backup pacing off and on again to reset the parameters. " Ensure that the system is only operated by trained users. The firm plans to do the following: " provide an amendment to the hardware manual concerning the correct use of the backup pacing functionality to all service partners and customers. An updated software, which prevents accidental change of backup pacing parameters will be made available. Upon receipt of the amendment and installation of the software update, the completed feedback form must be returned to CardioTek no later than 3/4/2018 by fax +49 7131 2774 590 or email: [email protected]. If you have any questions, please contact Sales & Service at +49 172 790 9112 or email: [email protected].
Quantity in commerce: 8 units US
Distribution: 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.
Product codes and lots: All EP-Tracer -FSCA-identifier (2017-04-06)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2657-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2657-2017	Class II	Completed	Voluntary: Firm initiated	2017-07-12	2017-06-30

Product code DQK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)