FDAClass IIMay 24, 2023

Philips Incisive CT -Computed Tomography X-Ray System recall

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

Why was Philips Incisive CT -Computed Tomography X-Ray System recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: (01)00884838105508(21) + Serial number US Serial Numbers: 550243, 34111, 34092, 34066, 34064, 34047, 34042, 34025, 34031, 34033 OUS Serial Numbers: System Serial Number 550263 550249 550239 550215 550211 550091 550188 550187 550186 550174 550172 552041 550164 34107 550140 34062 550099 550082 550071 550068 550059 34020 550038 550040 550021 550036 550018 550014 550011 550010 550009 550008 550007 550240 550126 550241

Product
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
Recalling firm
Philips North America
Quantity
10 units US; 36 units OUS
Distribution
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.
Recall date
May 24, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls