Philips North America recalled 2,341 Incisive CT systems worldwide after screws securing the tube heat exchanger on the rotating scanner may loosen after replacement. A detached component could contact other parts during rotation. Hospitals should stop using affected devices and await recall instructions from Philips.
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter
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Incisive CT is a computed tomography system used in hospitals for diagnostic imaging. It integrates rotating scanners and tube heat exchangers to acquire detailed body scans.
If the screws on the tube heat exchanger are not tightened after replacement, a component may detach and contact other components during rotation. This could cause damage to the scanner assembly.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals may need to halt imaging work on affected units and schedule service to repair or replace components. Downtime could affect diagnostic workflows and patient care.
Serial numbers and UDI-DI appear on the device data plate and packaging. The recall letter will specify included units.
Timeline for refunds or replacements not specified in the recall notice.
Keep the recall notice, service paperwork, serial numbers, and correspondence. Take photos of the device labeling and any service actions.
Model Number: 728143. UDI-DI: 00884838085015. Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102. Sold worldwide to healthcare providers. Distribution: Worldwide distribution including US nationwide and many countries listed in the recall notice. Recall Date: 2025-10-29. Report Date: 2025-12-10. Quantity: 2341 units. Country of origin: Unknown. Remedial action: Stop using the device and follow recall instructions from Philips North America LLC.
No injuries or incidents have been reported.
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