Philips Incisive CT Scanner Mounting Box Poses Injury Risk
A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed 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 of a medical device with a potential risk of user injury from a detached component. No injuries or hospitalizations have been reported, meeting the threshold for High severity as a risk-of-harm product without yet-reported injury.
Plain-English summary
The Incisive CT Power (Model 728148) is a computed tomography X-ray scanner used in medical imaging. A metal mounting box that forms part of the rotating scanner's heat exchanger may detach from its current position within the system.
If the metal mounting box detaches, two problems may occur: the loose part could make contact with other internal components and potentially cause injury to the operator or technician, or the system may shut down after emitting a loud noise when the part separates.
The recall affects 53 units that were distributed outside the United States, with installations in over 50 countries including China, Canada, Europe, Asia, and the Middle East.
Healthcare facilities and imaging centers with affected serial numbers should contact Philips North America for service instructions. The FDA recall number is Z-2260-2023.
The recalled product
- Product
- Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
- Manufacturer
- Philips North America
- Hazard
- component-detachment
- injury-risk
- equipment-failure
Distribution
Distributed nationwide across the United States.
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