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 Philips Incisive CT scanner is a medical imaging device used for diagnostic purposes in healthcare settings. These devices are crucial for obtaining detailed images of the body, aiding in accurate diagnosis and treatment planning.
The risk arises from improperly tightened screws on the tube heat exchanger, which can lead to detachment during operation. This poses a danger as it may damage other essential components of the CT system.
This recall is not part of a broader industry pattern.
The recall affects a limited number of devices, but immediate action is necessary to prevent potential damage to the CT system and ensure patient safety.
Model numbers and serial numbers are typically found on the back or bottom of the device. Refer to the user manual for specific locations.
Expect a response regarding refund or replacement within 4-6 weeks after contacting Philips North America.
Keep a record of all correspondence with Philips, including emails, letters, and any documentation related to the recall.
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.
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