HIGH

Philips CT System Recalled Due to Hazardous Component Misalignment

Philips recalled 14 Brilliance iCT SP CT systems on August 13, 2025. The patient support table may descend unexpectedly due to a component misalignment. The recall affects devices distributed worldwide, including the US and 49 other countries.

Hazard Information

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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

Product Details

The recalled product is the Brilliance iCT SP, Model Number: 728311. These CT systems were distributed globally, including the US, Argentina, Australia, and many European countries. The quantity recalled is 14 units.

The Hazard

The patient support table may descend unexpectedly to its lowest position. This poses a high risk of injury to patients during use.

Reported Incidents

No specific incidents have been reported yet. The recall is classified as Class II, indicating a high hazard level.

What to Do

Stop using the device immediately. Contact Philips North America or your healthcare provider for further instructions and follow the recall guidelines.

Contact Information

For more information, visit Philips North America's website or call customer service. Additional details are available at the FDA's recall report link.

Key Facts

  • Product: Brilliance iCT SP, Model Number: 728311
  • Recall Date: August 13, 2025
  • Quantity Recalled: 14 units
  • Hazard: Patient support table may descend unexpectedly
  • Countries Affected: Worldwide distribution
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Safety Assessment

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

Product Classification

Product Details

Model Numbers
728311
200016
200024
200211
200041
+10 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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