Baxter Epiphany Cardio Server E3 ECG Management System Servers with… — Class II medical device recall Z-2647-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2023-10-04, distributed nationwide. Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Serve
| Recall number | Z-2647-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-08-10 |
| Classified | 2023-09-28 |
| Reported by FDA | 2023-10-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA |
| Quantity | 89 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00860991000355, 00860991000362, 00860991000379 |
Product
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Reason for recall
Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.
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-2647-2023. 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.