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OneView

SCOTTCARE CORPORATION, THE · Model OneView · UDI-DI 00856298006206

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

ScottCare’s OneView is an innovative, cardiology software tool used to simplify and streamline the pacemaker/ICD monitoring session reporting process by consolidating all device manufacturers’ session data into one, convenient platform. With a click of a button, OneView captures all relevant pacemaker/ICD data, including:  Device specifications  Measurements for every session  Settings  Episode details  Reports  Physician sign-off OneView also provides insight into historical patient trends and other critical clinical data over time, helping to prioritize patients with more severe issues. In addition, data can be gathered from almost anywhere, as it supports remote interrogation, in-person interrogation and in-person programming.

Recalls

Date	Firm	Reason
2026-04-21	GE Medical Systems China Co., Ltd.	Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient.
2015-09-03	Spacelabs Healthcare Inc	When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. T
2015-01-09	Alivecor SFO	Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
2011-09-26	Lifewatch Services Inc	LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
2011-09-26	Lifewatch Services Inc	LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
2011-09-26	Lifewatch Services Inc	LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
2008-01-23	Cybernet Systems Corp.	A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo
2008-01-23	Cybernet Systems Corp.	A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo
2008-01-23	Cybernet Systems Corp.	A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo
2008-01-23	Cybernet Systems Corp.	A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo

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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.