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ViSi

Sotera Wireless, Inc. · Model Chest Sensor, 5 Lead, IEC, WH · UDI-DI 00850733007063

DRT Prescription

510(k) clearances

3,115

Adverse events (576 deaths)

Recalls

103

Facilities

Description

ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure ECG, heart rate, respiration rate and temperature of adult patients (18 years or older).

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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Data 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.