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.
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: 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
- 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.
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