Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- United StatesEpiphany Cardio Server 00860991000324
Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-01-09 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 1 |
| 2023-08-17 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 1 |
| 2018-07-19 | NAI | No action indicated | Welch Allyn, Inc. | 0 |
| 2015-06-10 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 3 |
| 2014-08-13 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 1 |
| 2012-10-19 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 0 |
| 2012-06-25 | VAI | Voluntary action indicated | Welch Allyn, Inc. | 7 |
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