HIGH

Philips CT System Recalled Due to Patient Safety Hazard

Philips recalled 210 Brilliance iCT CT systems on August 13, 2025. A misalignment in the ball screw may cause the patient support table to descend unexpectedly. Patients and healthcare providers must stop using the device immediately.

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 Philips Brilliance iCT, Model Number 728306. It has a Unique Device Identifier (UDI-DI) of 00884838059474. The recall affects 210 units distributed worldwide, including the U.S. and several other countries.

The Hazard

The patient support table (couch) may descend unexpectedly to the lowermost position. This poses a high risk of injury to patients during use.

Reported Incidents

No specific incidents have been reported to date, but the potential for injury is classified as high.

What to Do

Stop using the device immediately. Follow the recall instructions provided by Philips. Contact Philips North America or your healthcare provider for further guidance.

Contact Information

For more information, call Philips North America at 1-800-xxx-xxxx or visit www.philips.com/recall. Further details are available at the FDA recall page.

Key Facts

  • Recall date: August 13, 2025
  • 210 units affected
  • Worldwide distribution
  • High hazard level
  • Immediate action required
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Safety Assessment

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

Product Details

Model Numbers
728306
00884838059474
100068
100188
100241
+15 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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