Home › INTELESENS LIMITED › Zensoronline software

Zensoronline software

INTELESENS LIMITED · Model PN0810 · UDI-DI 05060484630044

MHX Prescription

510(k) clearances

33,126

Adverse events (1,928 deaths)

294

Recalls

118

Facilities

Description

The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.

Recalls

Date	Firm	Reason
2026-09-16	Philips North America	Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity t
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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.