Philips Incisive CT System Recalled for Gantry Actuator Failure Risk
Philips is recalling 105 Incisive CT Computed Tomography X-ray Systems because gantry actuators may fail, causing the gantry to tilt forward.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Philips North America LLC is recalling 105 units of the Incisive CT Computed Tomography X-ray System, Model 728143. The recall affects one unit in the United States and 104 units distributed internationally to countries including Australia, China, Germany, Japan, and others.
The recall is due to a defect in the actuators within the Incisive gantry. If actuators on both sides fail, the gantry may fail to self-lock. In some cases, the gantry may tilt forward slowly, potentially reaching a tilt limit angle of +31 degrees in a worst-case scenario.
Healthcare facilities should contact Philips North America LLC for instructions on how to address the defect. No specific consumer action is required for the general public, as these are professional medical devices.
The recalled product
- Product
- Incisive CT Computed Tomography X-ray System Model: 728143
- Manufacturer
- Philips North America Llc
Distribution
Distribution scope not specified by the agency.
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