HIGH

Philips CT Scanner Recalled Due to Detachment Risk

Philips North America recalled 2,341 Incisive CT scanners on October 29, 2025. A component may detach and damage other parts during operation. Users must stop using the device immediately and follow recall instructions.

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 Incisive CT scanners with software versions 4.5, 5.0, and 5.1. The model number is 728143, and serial numbers include 500092, 500202, and more. These units were distributed worldwide, including the US, since their release.

The Hazard

If screws on the tube heat exchanger are not tightened properly, the component can detach during operation. This poses a risk of damaging other internal components, which could lead to malfunctions.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. However, the potential for equipment damage exists.

What to Do

Stop using the Incisive CT scanner immediately. Follow the recall instructions provided by Philips North America. Contact your healthcare provider for further instructions.

Contact Information

For more information, contact Philips North America at 1-800-XXX-XXXX or visit their website at www.philips.com.

Key Facts

  • Recalled units: 2,341
  • Affected models: Incisive CT scanners
  • Hazard: Detachment of tube heat exchanger screws
  • Recall date: October 29, 2025
  • Status: Active

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
1) Model Number: 728143
UDI-DI: 00884838085015
Serial Numbers: 500092
500202
500309
+15 more
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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