Home › Device types › DXH
Transmitters And Receivers, Electrocardiograph, Telephone
FDA product code DXH · Class 2 · Cardiovascular
185
Registered devices
72
Adverse events
10
Recalls
297
510(k) clearances
Devices with this code
MAC — GE Medical Systems Information Technologies, Inc.CloudEKG — NEUROSOFT, OOOSmartheart — SHL TELEMEDICINE INTERNATIONAL LTD.Heartrak 2 — UNIVERSAL MEDICAL, INC.HeartCheck CardiBeat — CardioComm Solutions, IncWithings® — WITHINGSSentinel — SPACELABS HEALTHCARE (WASHINGTON), INCRhythmStar — RHYTHMEDIX, LLCSENSINEL™ CPM ALIGNMENT TOOL — Analog Devices, Inc.Bittium Faros — Bittium Biosignals OyCardiostation® Advantage Software — UNIVERSAL MEDICAL, INC.PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.QT ECG — Qt Medical, Inc.Transtelephonic Receiving Module — SCOTTCARE CORPORATION, THELifeWatch Mobile Cardiac Telemetry 3-Lead — LifewatchNA — PROTEUS DIGITAL HEALTH, INC.QT ECG — Qt Medical, Inc.Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INCPACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.LifeWatch Mobile Cardiac Telemetry 1 Lead Patch — LifewatchECG — VITALOGRAPH (IRELAND) LIMITEDComplete Blood Pressure Monitor +EKG — Omron Healthcare, Inc.ECG Check — CARDIAC DESIGNS INC.Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | GE Medical Systems China Co., Ltd. | Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the |
| 2015-09-03 | Spacelabs Healthcare Inc | When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when b |
| 2015-01-09 | Alivecor SFO | Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with |
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