Z-2608-2023 Class II Ongoing
FDA device recall Z-2608-2023 was initiated by Philips North America Llc on August 17, 2023 and is designated Class II. Reason for recall: 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 c… The recall status is ongoing. Affected quantity: 960 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 960 units
Product Description
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
Reason for Recall
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
Distribution Pattern
Nationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark Finland France Germany Greece India Ireland Italy Japan Jordan Kenya Kuwait Lebanon Lithuania Netherlands Norway Poland Portugal Qatar Romania Slovakia South Africa South Korea Spain Sweden Sweden Switzerland United Kingdom Utd.Arab.Emir. Uzbekistan
Code Information
UDI: (01)00884838104594(10)4.0.1 (01)00884838104594(10)4.0.2 (01)00884838112070(10)4.1.0 Software Version Number 4.x