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ViSi Mobile System Package

Sotera Wireless, Inc. · Model 5-lead AAMI · UDI-DI 00850733007117

MHX Prescription

510(k) clearances

33,126

Adverse events (1,928 deaths)

293

Recalls

118

Facilities

Description

The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments. The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication. The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device.

Recalls

Date	Firm	Reason
2026-09-08	Nihon Kohden America LLC	Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-08-31	Mindray DS USA, Inc.	Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.
2026-07-31	Philips North America	Due to software malfunction, patient information system may freeze and become unresponsive.
2026-06-05	Philips North America Llc	Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PI

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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.