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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Philips Medical Systems Nederland B.V. recalls 8 Allura Xper FD20/15 OR Tables worldwide due to a risk that X-ray imaging may not start or may stop intermittently when using the wired foot switch. The issue is tied to System Code 722059 and requires immediate action. Hospitals and patients should stop using the device and follow the manufacturer’s recall instructions.
Philips recalled 1,994 Azurion 7 M12 interventional X-ray systems, including 360 units in the United States, for a wiring-foot switch defect that may fail to initiate imaging. The issue can cause imaging to not start or operate intermittently. Hospitals and clinicians should stop using affected devices immediately and follow the manufacturer’s recall instructions.
Philips Medical Systems Nederland B.V. recalled 461 Allura Xper FD20 Biplanes sold to healthcare facilities nationwide and internationally. X-ray imaging may not initiate or may occur intermittently when using the wired foot switch. Hospitals should stop using the devices immediately and follow Philips’ recall instructions.
Philips Medical Systems Nederland B.V. recalls 1,523 Azurion 7 B20 interventional X-ray systems used by hospitals nationwide after possible failure to initiate X-ray imaging. The defect affects whether imaging starts when using the wired foot switch. Hospitals should stop using the device and follow Philips recall instructions immediately.
Philips recalled 7,129 Tempus Pro Patient Monitors on November 26, 2025. The monitors may provide unvalidated measurements for Intracranial Pressure and Bladder Pressure. Incorrect readings could lead to critical clinical decisions.
Philips North America is recalling 1,913,441 IntelliVue MP2 patient monitors worldwide. The devices may fail to alarm when critical conditions arise. Hospitals should stop using the monitors and follow Philips recall instructions.
Philips recalls 1.913 million IntelliVue MP20 patient monitors worldwide because the devices may fail to alarm. The issue could prevent critical alerts from sounding. Hospitals should stop using the monitors immediately and follow Philips recall instructions.
Philips North America is recalling 1,913,441 IntelliVue MP60 patient monitors. The monitors may fail to alarm as designed. Hospitals and clinics using MP60 units should stop using the devices and follow the recall instructions.