Agency classClass IIOur severity:High FDA (Devices)·Z-1586-2023·Announced 2023-05-24

Philips Incisive CT System Foot Switch Pedal May Cause Foot Entrapment Injury

Philips Incisive CT System foot switch unload pedal may trap an operator's foot, causing injury. The FDA is recalling 5 units (3 in the US, 2 internationally) with this entrapment hazard.

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: FDA Class II recall involving a physical entrapment hazard on medical imaging equipment. No injuries have been reported in the source text, but the foot switch pedal poses a risk of foot and leg injury to operators during normal use.

Plain-English summary

Philips North America is recalling the Incisive CT Computed Tomography X-Ray System, Model Number 72813. The multi-function foot switch unload pedal may trap an operator's foot when pressed, creating a risk of injury to the foot and leg.

This is a Class II recall issued by the U.S. Food and Drug Administration. The hazard affects the unload function pedal on the foot switch, which operators use during normal system operation.

Five units have been distributed: three in the United States (in Arkansas, California, Florida, Illinois, Indiana, Michigan, Missouri, New York, Tennessee, Texas, and Vermont) and two internationally (in 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 U.S. serial numbers are 33041, 500301, and 500252. International serial numbers are 33040 and 500408.

Operators should cease using the unload pedal function and contact Philips North America for instructions on how to address this issue. Facilities operating this equipment should verify their unit's serial number against the recall list to determine if they are affected.

The recalled product

Product: Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Manufacturer: Philips North America
Category: Medical Device — CT Scanner
Hazard: foot-entrapment
injury-risk

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 (4)

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

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