Philips CT scanner heat exchanger box may detach and cause injury
The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.
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: This is an FDA Class II medical device recall involving potential risk of user injury from an expelled metal component. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Philips North America has recalled certain units of the Incisive CT-Computed Tomography X-Ray System, Model 728143. The recall affects 36 units distributed in the United States and 610 units distributed internationally across multiple countries.
A metal mounting box located on the rotating scanner (referred to as the heat exchanger box or rotor) within the system may become detached or expelled during operation. This component is mounted on the scanner's rotating assembly.
If the metal box becomes detached and makes contact with other internal components, it may cause injury to users. If the box detaches, the system will emit a loud noise and shut down, preventing further diagnostic procedures.
Healthcare facilities and users with affected systems should verify their unit's serial number against the manufacturer's recall list. Contact Philips North America for instructions on replacement, repair, or other remedial actions.
The recalled product
- Product
- Incisive CT-Computed Tomography X-Ray System Model: 728143
- Manufacturer
- Philips North America
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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.
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