FDA-Device2023-05-24Class II

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814

Philips North America
Hazard

Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury

Sold states
Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, MI, MO, NY, TN, TX, VT and the countries of Australia, Chile, Costa Rica, Czech Republic, Dominican, Republic Germany, India, Israel, Japan, Lithuania, Philippines, Poland, Sint Maarten (Dutch part), South Africa, Thailand, United Kingdom, Utd. Arab. Emir.
Affected count
10 units US; 36 units OUS
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1585-2023

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