FDA-Device2021-08-25Class II

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

Philips North America Llc
Hazard

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Sold states
US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Affected count
3 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2314-2021

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