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Cardio Server
Model 6.1 · EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC · DI 00860991000355
DQK — Computer, Diagnostic, Programmable · Class II · 21 CFR 870.1425
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2023-08-10
Z-2647-2023
Class II
Open, Classified
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.
code info di
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
3.13
2019-02
0
1.7
2019-03
0
3.83
2019-04
0
2.7
2019-05
0
2
2019-06
0
3
2019-07
0
2.88
2019-08
0
2.33
2019-09
0
2.44
2019-10
0
3.36
2019-11
0
2.23
2019-12
0
2.67
2020-01
0
1.83
2020-02
0
2.46
2020-03
0
3.75
2020-04
0
2.4
2020-05
0
2.5
2020-06
0
1.91
2020-07
0
2.27
2020-08
0
2.62
2020-09
0
1.9
2020-10
0
2.5
2020-11
0
3.36
2020-12
0
2.7
2021-01
0
3.2
2021-02
0
2.9
2021-03
0
2.8
2021-04
0
3.38
2021-05
0
7.33
2021-06
0
2.91
2021-07
0
2.5
2021-08
0
5.1
2021-09
0
4.07
2021-10
0
2.59
2021-11
0
3.31
2021-12
0
4.33
2022-01
0
4.56
2022-02
0
4
2022-03
0
4.38
2022-04
0
4.11
2022-05
0
3.33
2022-06
0
2.94
2022-07
0
2.77
2022-08
0
2.29
2022-09
0
3.67
2022-10
0
3.25
2022-11
0
2.4
2022-12
0
3.54
2023-01
0
3.3
2023-02
0
3.76
2023-03
0
3.38
2023-04
0
3.2
2023-05
0
3.22
2023-06
0
3.85
2023-07
0
2.42
2023-08
0
2.6
2023-09
0
2.62
2023-10
0
2.39
2023-11
0
4.15
2023-12
0
8.23
2024-01
0
4.16
2024-02
0
5.55
2024-03
0
4.5
2024-04
0
5.75
2024-05
0
6.11
2024-06
0
7.11
2024-07
0
3
2024-08
0
4.38
2024-09
0
5.83
2024-10
0
3.56
2024-11
0
4.41
2024-12
0
2.79
2025-01
0
4.16
2025-02
0
3.33
2025-03
0
3.4
2025-04
0
3.6
2025-05
0
5.39
2025-06
0
1.78
2025-07
0
3
2025-08
0
2.63
2025-09
0
2.36
2025-10
0
2.42
2025-11
0
3.21
2025-12
0
2.65
2026-01
0
3.43
2026-02
0
3.65
2026-03
0
2.22
2026-04
0
2.5
2026-05
0
2.64
2026-06
0
2.26
This device (reports/month)Average device in DQK (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K052883 — cited as predicate by K103427, K123466, K180432, K181720
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC