FDA Device recall 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, digitiz…
- FDA Device
- Class II
- completed
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class II recall of CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitiz… by Cardiotek Bv, citing software bug which allows parameters to be changed unintentionally during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2657-2017 |
| Classification | Class II |
| Status | completed |
| Initiated | 2017-04-13 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cardiotek Bv |
| Distribution | US |
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
Software bug which allows parameters to be changed unintentionally during use.
Identifiers
| code_info | All EP-Tracer -FSCA-identifier (2017-04-06) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2657-2017%22
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