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Model 7800
IVY BIOMEDICAL SYSTEMS, INC. · Model 3304-30-15 · UDI-DI 00816396020719
DRT
Prescription
1
510(k) clearances
3,110
Adverse events (575 deaths)
11
Recalls
103
Facilities
Description
Cardiac Gating Monitor & Accessory Kit
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 connectivity issues. |
| 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 or flash very fast |
| 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 occurs, a Pulse Ox Sens |
| 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 flash very fast. Th |
| 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-Lead ECG data. |
| 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-Lead ECG data. |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.