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Decisio Health Patient Dashboard

DECISIO HEALTH, INC. · Model 2 · UDI-DI 00865683000309

MWI Prescription

510(k) clearances

1,983

Adverse events (45 deaths)

Recalls

171

Facilities

Description

The Decisio Health Patient Dashboard (“Patient Dashboard”) is a data aggregation and visualization software device. The Patient Dashboard is designed to display patient information, facility specific care protocols, and visual cues to care providers on a single display device. The Patient Dashboard is configured to receive patient data through the facility’s Electronic Medical Record system and display information to the user on a patient monitor, computer, or a mobile device. Data received through the EMR includes input from various sources within the hospital, including manually entered data into the EMR (e.g., laboratory data), vital signs monitors, ventilators, IV pumps, and Foley catheter devices. The data the Patient Dashboard receives are then stored, filtered, and displayed through the Patient Dashboard web browser application. The Patient Dashboard is customized to individual facility’s care as it is programmed with the facility’s treatment protocols, which dictate the information that is displayed relative to those protocols. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.

Recalls

Date	Firm	Reason
2026-07-20	GE Medical Systems Information Technologies Inc	Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and
2026-07-20	GE Medical Systems Information Technologies Inc	Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and
2026-07-20	GE Medical Systems Information Technologies Inc	Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and
2026-07-20	GE Medical Systems Information Technologies Inc	Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and
2026-07-10	GE Medical Systems Information Technologies Inc	Portrait Core Services Software version V1.2.0 Security Vulnerability
2026-01-30	Covidien LLC	Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring s
2025-10-24	Edan Diagnostics	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
2025-05-22	CHANGE HEALTHCARE CANADA COMPANY	Due to complaints, software update may cause software to unexpectedly shutdown.
2025-05-22	CHANGE HEALTHCARE CANADA COMPANY	Due to complaints, software update may cause software to unexpectedly shutdown.
2025-03-24	Baxter Healthcare Corporation	There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batter

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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.