Home › Device types › DRT
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
FDA product code DRT · Class 2 · Cardiovascular
513
Registered devices
3,110
Adverse events
11
Recalls
339
510(k) clearances
Devices with this code
CAB,3 LD,MRI EKG,SIEMENS — Philips Ds North America LLCCARESCAPE B850 — GE Healthcare Finland OyModel 7800 — IVY BIOMEDICAL SYSTEMS, INC.Model 7800 — IVY BIOMEDICAL SYSTEMS, INC.Model 7800 — IVY BIOMEDICAL SYSTEMS, INC.PROPAQ M — Zoll Medical CorporationPatient Monitor — Edan Instruments, Inc.Model 7600 — IVY BIOMEDICAL SYSTEMS, INC.Model 7700 — IVY BIOMEDICAL SYSTEMS, INC.RespArray — Edan Instruments, Inc.Model 7800 — IVY BIOMEDICAL SYSTEMS, INC.BluPRO® — NIHON KOHDEN AMERICA, INC.Model 7700 — IVY BIOMEDICAL SYSTEMS, INC.Model 7600 — IVY BIOMEDICAL SYSTEMS, INC.Model 7600EP — IVY BIOMEDICAL SYSTEMS, INC.PROPAQ M — Zoll Medical CorporationNA — NIHON KOHDEN CORPORATIONModel 7800 — IVY BIOMEDICAL SYSTEMS, INC.Model 7800 — IVY BIOMEDICAL SYSTEMS, INC.Model 7600 — IVY BIOMEDICAL SYSTEMS, INC.Patient Monitor — Edan Instruments, Inc.ECG — Zoll Medical CorporationNA — NIHON KOHDEN CORPORATIONPROPAQ M — Zoll Medical Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-09 | Murata Vios, Inc. | Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivi |
| 2024-04-22 | Murata Vios, Inc. | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker |
| 2023-06-06 | Murata Vios, Inc. | A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occ |
| 2021-06-21 | Murata Vios, Inc. | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or |
| 2014-07-01 | Ansar Group, Inc. Dba Ansar Medical Technologies, Inc | The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured. |
| 2011-10-14 | Mindray DS USA, Inc. d.b.a. Mindray North America | A system database corruption may occur that causes the V Series Monitor to reset. |
| 2005-09-07 | Datascope Corp | Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12- |
| 2005-09-07 | Datascope Corp | Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12- |
| 2005-08-19 | Datascope Corp | The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse. |
| 2005-06-16 | Datascope Corp | Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages. |
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