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IntelliVue GuardianSoftware

Philips Medizin Systeme Böblingen GmbH · Model IntelliVue GuardianSoftware · UDI-DI 00884838081925

DXJ Prescription
10
510(k) clearances
525
Adverse events (15 deaths)
21
Recalls
38
Facilities

Description

IntelliVue GuardianSoftware is a software-only product. It is the core of the Guardian General Care Solution, which provides fully customizable workflow support for automated vital signs taking, early warning scoring, patient deteroration detection, caregiver notification and care escalation for medical/surgical care, ED waiting/triage and other general care areas. It also mediates the data flow between the devices and hospital systems. Guardian Software license options listed enable desired features and capabilities for specified number of patients, clients, selected measurement technologies as well as required connectivity to hospital systems.

Recalls

DateFirmReason
2025-09-05Wipro GE Healthcare Private Ltd.Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patien
2025-09-05Wipro GE Healthcare Private Ltd.Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patien
2025-05-09Barco N.V.Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, vi
2024-04-24Barco N.V.We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDM
2022-07-27BARCO NVinstallation issues
2022-05-10GE Healthcare, LLCThe CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
2022-01-28GE Healthcare, LLCIf the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
2011-07-08Philips Healthcare Inc.Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventi
2010-10-19Philips Healthcare Inc.Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending
2009-11-06Spacelabs Healthcare, IncorporatedPotential for monitor to shut down and not being able to power on again.

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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.