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TGA Action ID RC-2026-RN-00634-1
Type of Product Medical Device
Product Name/Description Philips Patient Information Centre iX (PIC iX) 4.x systems

Patient Information Center iX
Model: 866389

IntelliVue Information Center iX
Model: 866389

PIC iX Essentials
Model: 867093
ARTG Number 384159
Unique Device Identifier (UDI) N/A
Action Type Product Correction
Action Level Hospital
Hazard Classification Class II
Reason for the Action Failure of the watchdog may cause the system to be in
an unknown state and therefore potentially prevent alarms from being generated or logged.
Following the initial system error which triggers the watchdog, staff may observe unexpected system behaviour while the watchdog attempts recovery. The observed behaviour depends on the underlying software problem and may include:
- Inability to interact with the PIC iX user interface. If real-time waveforms, numeric data, and alarms remain operational, there is no impact to bedside or central monitoring and alarming.
- The user will not recognise the device problem before the hazardous situation occurs if the observed behaviour is: Loss of central alarming, loss of, or frozen, waveforms/data display
- Bedside monitors and Telemetry devices could generate a ‘No Central Mon’ INOP.

The failure of the watchdog may cause the system to remain in an unknown state during which central monitoring and alarming may not occur. This may also be associated with a failure of connected telemetry devices to disconnect and provide local alarming. While this harm has not been demonstrated to date, there is evidence of events involving frozen data and absent alarming occurring which required manual intervention to resolve.
Instructions for Customers/Users Customers are to:
- Increase bedside monitoring and adjust workflows where central monitoring has halted to ensure patients are appropriately observed.
- Ensure bedside alarm volumes are set appropriately to facilitate detection of alarms if communication with the central station is disrupted.
- Implement the software update when it becomes available.
Philips will contact customers to arrange a software update to correct the reported problems.
Action Commencement Date 27/08/2026
Responsible Entity Philips Electronics Australia Ltd
Contact Information 1800 251 400.- Philips Service Delivery Team