Device product

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813

Z-1586-2023

March 20, 2023

Class II

Product summary

Firm: Philips North America
Event: Event 92117
Status: Ongoing
Classification: Class II
Quantity: 3 units US ;2 units OUS
Official record key: device-enforcement:Z-1586-2023

Official wording

Reason: 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

Code information: UDI-DI:(01)00884838085015(21) + Serial number US Serial Numbers: 33041, 500301, 500252. OUS Serial Numbers: 33040, 500408

Distribution pattern: 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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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