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Electrocardiograph, Ambulatory (Without Analysis)
FDA product code MWJ · Class 2 · Cardiovascular
456
Registered devices
63
Adverse events
5
Recalls
62
510(k) clearances
Devices with this code
Norav NR Series — NORAV MEDICAL LTD.ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AGSEER 1000 — getemed Medizin- und Informationstechnik AGH12+ — MORTARA INSTRUMENT, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.MonitorMe — Lifesignals, Inc.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Advance Biometrix — Lifesignals, Inc.Eclipse Pro — SPACELABS HEALTHCARE (WASHINGTON), INCECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AGDR400 — Northeast Monitoring, Inc.Sibel Spacelabs Trek Chest Patch Adhesive — Sibel Health Inc.Welch Allyn, Inc. — WELCH ALLYN, INC.Actiwave — CAMNTECH LIMITEDSPIDERVIEW — MICROPORT CRM SRLWelch Allyn, Inc. — WELCH ALLYN, INC.Biotres Pro — BIOTRICITY INC1-Day ANNE Chest Adhesive Pouch — Sibel Health Inc.HOLTER CONNECT — Lifesignals, Inc.Welch Allyn, Inc. — WELCH ALLYN, INC.SEER 1000 — getemed Medizin- und Informationstechnik AGSpacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INCWelch Allyn, Inc. — WELCH ALLYN, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-25 | Spacelabs Healthcare, Ltd. | Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the de |
| 2024-11-25 | Spacelabs Healthcare, Ltd. | Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the de |
| 2020-01-22 | Braemar Manufacturing, LLC | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar |
| 2020-01-22 | Braemar Manufacturing, LLC | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar |
| 2020-01-13 | Philips North America, LLC | if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display |
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