CardioTek EP-TRACER Software V1 — Class II medical device recall Z-2657-2017
Completed recall by CardioTek BV, reported 2017-07-12, distributed nationwide. Software bug which allows parameters to be changed unintentionally during use.
| Recall number | Z-2657-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | CardioTek BV, Maastricht-Airport, N/A, Netherlands |
| Recall initiated | 2017-04-13 |
| Classified | 2017-06-30 |
| Reported by FDA | 2017-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BD, BE, BO, BR, CA, CH, CL, CO, CR, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, KW, LB, LK, LT, LV, MA, MT, MX, MY, NL, NO, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, TR, TT, VE, VN, ZA |
| Quantity | 8 units |
| Reason classes | software |
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.
Reason for recall
Software bug which allows parameters to be changed unintentionally during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2657-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.