Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported July 12, 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.
Software bug which allows parameters to be changed unintentionally during use.
CardioTek Bv recalled CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiolog… - a moderate-severity action.
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiolog… was recalled by CardioTek Bv in July 12, 2017. Reason: Software bug which allows parameters to be changed unintentionally during use.. Check the official notice for the remedy. Verify recall #Z-2657-2017 with the FDA Devices before acting.
The recall
CardioTek Bv issued this moderate-severity FDA Devices recall-Software bug which allows parameters to be changed unintentionally during use..
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- July 12, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2657-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2657-2017) was formally reported on July 12, 2017, with the manufacturer initiating the action on April 13, 2017. It is classified under Moderate severity (Class II), with a current status of Completed. CardioTek Bv is listed as the recalling firm, operating out of Maastricht-Airport, N/A. Federal records list the affected scope as 8 units US.
The documented reason for this recall is: Software bug which allows parameters to be changed unintentionally during use. Distribution data in the federal record shows the product reached: 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 Re…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8 units US
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-2657-2017 |
| Date reported | July 12, 2017 |
| Date initiated | April 13, 2017 |
| Recalling firm | CardioTek Bv |
| Firm location | Maastricht-Airport, N/A |
| Affected scope | 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,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2657-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CardioTek Bv. Units affected: 8 units US.
Why was this product recalled? ▼
Software bug which allows parameters to be changed unintentionally during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2017. Severity: Moderate. Recall number: Z-2657-2017.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2657-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 12, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.