HIGH

Philips Recalls CT Systems Over Risk of Unexpected Descent

Philips recalled 285 CT systems on August 13, 2025, due to a risk of patient support tables descending unexpectedly. The recall affects model numbers 728321, 728323, and 728326. Users should stop using the devices immediately and follow manufacturer instructions.

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 recall includes Philips Ingenuity CT systems, specifically model numbers 728321, 728323, and 728326. The devices were distributed worldwide, including in the United States and several countries across Europe, Asia, and South America.

The Hazard

The patient support table may descend unexpectedly to the lowermost position due to a misalignment of a component known as the ball screw. This situation poses a high hazard level, potentially leading to serious injury.

Reported Incidents

There have been no specific reports of injuries associated with this recall. Philips issued this recall proactively after identifying the potential risk.

What to Do

Stop using the affected devices immediately. Contact Philips North America or your healthcare provider for further instructions regarding the recall.

Contact Information

For more information, contact Philips North America at 1-800-xxx-xxxx or visit the recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2600-2025.

Key Facts

  • 285 units recalled
  • Affected models: 728321, 728323, 728326
  • Potential for unexpected descent of patient support table
  • Immediate cessation of use required
  • Worldwide distribution of affected units
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Safety Assessment

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

Product Details

Model Numbers
728321
728323
728326
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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