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Electrocardiograph
FDA product code DPS · Class 2 · Cardiovascular
3,337
Registered devices
868
Adverse events
98
Recalls
576
510(k) clearances
Devices with this code
Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Patient Cable Lead Set — MORTARA INSTRUMENT, INC.CONTEC — Contec Medical Systems Co., Ltd.CONTEC — Contec Medical Systems Co., Ltd.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.M SERIES BIPHASIC — Zoll Medical CorporationVelocity Pro — AvanteWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.M SERIES BIPHASIC — Zoll Medical CorporationWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.M SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Midmark Corporation | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
| 2026-07-01 | Philips North America Llc | Device will intermittently provide inaccurate data related to native heart rate. |
| 2026-07-01 | Philips North America Llc | Device will intermittently provide inaccurate data related to native heart rate. |
| 2026-06-29 | GE Medical Systems Information Technologies Inc | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically |
| 2025-09-12 | Philips North America | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| 2025-09-12 | Philips North America | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| 2025-08-22 | GE Medical Systems, LLC | If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cab |
| 2025-03-24 | Baxter Healthcare Corporation | There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, |
| 2024-12-18 | Braemar Manufacturing, LLC | Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled wi |
| 2024-10-11 | Baxter Healthcare Corporation | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and |
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