Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2608-2023 — 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 Num

U.S. FDA — Device Enforcement · United States · 2023-08-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2608-2023
Date of alert
2023-08-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838104594
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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