Philips Patient Information Center iX Software Crashes Delay Patient Monitoring
Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall affects a patient monitoring system where software crashes can delay the detection of patient condition changes. As no illnesses or injuries are reported and the hazard remains theoretical without documented harm, this qualifies as a risk-of-harm scenario without reported injury, scoring 3 (High) per the severity rubric.
Plain-English summary
Philips North America LLC is recalling Patient Information Center iX systems with software version 4.x, affecting four product models: Patient Information Center iX (Product 866389), Patient Information Center iX Expand (Product 866390), PIC iX Essentials (Product 867093), and PIC iX Essentials Expand (Product 867154). The recall affects approximately 960 units.
The systems are susceptible to software crashes caused by an Intel Graphics Driver error. When a crash occurs, the system displays a blank screen and requires a manual reboot to restart and resume central patient monitoring functions.
The malfunction creates a potential for delay in the detection of changes or deterioration in patient conditions. The affected units are distributed nationwide and internationally.
The recalled product
- Product
- Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX…
- Manufacturer
- Philips North America Llc
- Affected units
- 960
Distribution
Distributed nationwide across the United States.
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