Philips North America recalled six units of the Incisive CT scanner on October 29, 2025, due to a serious safety hazard. The screws on the tube heat exchanger may not be properly tightened, leading to potential detachment during operation. This defect could cause damage to other components within the system.
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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The recall affects the Incisive CT systems with software versions 4.5, 5.0, and 5.1. Model number 728285 and serial numbers include 35071, 800001, 800002, 800003, 800004, and 800007. The devices were distributed worldwide, including the US and various countries.
If the screws of the tube heat exchanger are not adequately tightened, the component may detach. This detachment can result in damage to other critical components of the CT system during rotation.
No specific incidents or injuries have been reported. However, the potential risk of component damage poses a significant operational hazard.
Stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact Philips North America or your healthcare provider for further instructions.
For more information, contact Philips North America at their customer service number or visit their website.
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