Philips CT Scanner Recalled Over Potential Detachment Hazard
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.
Quick Facts at a Glance
Recall Date
October 29, 2025
Hazard Level
HIGH
Brand
Philips North America
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
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.
What You Should Do
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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Product Details
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.
The Hazard
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.
Reported Incidents
No specific incidents or injuries have been reported. However, the potential risk of component damage poses a significant operational hazard.
What to Do
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.
Contact Information
For more information, contact Philips North America at their customer service number or visit their website.
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