HIGH

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.

Key Facts

  • Recall date: October 29, 2025
  • Report date: December 10, 2025
  • Quantity recalled: 6 units
  • Hazard level: High

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
1) Model Number: 728285
UDI-DI: 00884838113237
Serial Numbers: 35071
800007
800002
+3 more
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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