medical Class II Updated 2023-09-27

Philips North America Llc recalls Patient Information Center iX with Software Version Number 4

Recalled 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 Essentials Expand Product Number: 867154


Hazard / Issue

Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01)00884838104594(10)4.0.1 (01)00884838104594(10)4.0.2 (01)00884838112070(10)4.1.0 Software Version Number 4.x
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