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ZENSOR

INTELESENS LIMITED · Model PN0620 · UDI-DI 05060484630006

MHX Prescription

510(k) clearances

32,636

Adverse events (1,917 deaths)

286

Recalls

118

Facilities

Description

The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body. The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation). The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician.

Recalls

Date	Firm	Reason
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
2026-06-04	Spacelabs Healthcare, Inc.	Due to off-the-shelf display port component that has audio/video failures
2026-05-06	Criticare Technologies, Inc.	Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
2026-04-24	GE Medical Systems Information Technologies Inc	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result
2026-04-24	GE Medical Systems Information Technologies Inc	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result
2026-04-24	GE Medical Systems Information Technologies Inc	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result
2026-04-24	GE Medical Systems Information Technologies Inc	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result
2026-04-24	GE Medical Systems Information Technologies Inc	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result

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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.