HIGH

Philips Recalls CT Systems Over Hazardous Couch Descent

Philips recalled 33 CT systems on August 13, 2025, due to a risk of the patient support table descending unexpectedly. A misalignment in the ball screw can cause the couch to drop to its lowest position. The recall affects models distributed worldwide, including the U.S. and numerous 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 recall includes Philips models: Big Bore RT (Model Number: 728242), Brilliance CT Big Bore Oncology (Model Number: 728243), and Brilliance CT Big Bore (Model Number: 728244). These systems were distributed globally, including the United States and 33 other countries.

The Hazard

The patient support table may descend unexpectedly due to a misalignment in the ball screw component after replacement. This poses a serious risk to patient safety during imaging procedures.

Reported Incidents

There have been no specific reported injuries or fatalities associated with this defect. However, the potential for harm exists due to the sudden descent of the patient support table.

What to Do

Stop using the recalled CT systems immediately. Contact Philips North America or your healthcare provider for further instructions and follow the recall process outlined in the notification letter.

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-2597-2025.

Key Facts

  • 33 units recalled
  • Risk of unexpected descent of patient support table
  • Models affected: 728242, 728243, 728244
  • Worldwide distribution including the US
  • Contact Philips for further instructions
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Safety Assessment

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

Product Classification

Product Details

Model Numbers
728242
728243
728244
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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