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.
What this means for you
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.
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