Agency classClass IIOur severity:High FDA (Devices)·Z-1585-2023·Announced 2023-05-24

Philips Incisive CT system foot switch poses entrapment risk during unload

The Philips Incisive CT system's foot switch may trap the operator's foot during the unload function, causing injury. The FDA has issued a Class II recall affecting 46 units worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a mechanical hazard (foot entrapment) in a medical device with no reported injuries or illnesses, fitting the High severity criterion for risk-of-harm products without reported incidents.

Plain-English summary

Philips North America is recalling the Incisive CT Computed Tomography X-Ray System, Model 72814, due to a potential foot entrapment hazard in the multi-function foot switch.

The unload pedal of the foot switch may cause entrapment of the operator's foot during normal operation of the unload function, creating a risk of foot injury.

The recall affects 10 units in the United States (Arkansas, California, Florida, Illinois, Indiana, Michigan, Missouri, New York, Tennessee, Texas, and Vermont) and 36 units internationally across Australia, Chile, Costa Rica, Czech Republic, Dominican Republic, Germany, India, Israel, Japan, Lithuania, Philippines, Poland, Sint Maarten, South Africa, Thailand, United Kingdom, and United Arab Emirates. Affected systems are identified by specific serial numbers provided to the FDA.

The recalled product

Product: Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
Manufacturer: Philips North America
Category: Medical Device — Imaging Equipment
Hazard: foot-entrapment
injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

UDI-DI: (01)00884838105508(21) + Serial number US Serial Numbers: 550243
34111
34092
34066
34064
34047
34042
34025
34031

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Philips North America

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Same hazard · foot entrapment