HIGH

Philips Recalls CT Systems Over Risk of Unexpected Descent

Philips recalled 24 CT systems on August 13, 2025, due to a risk of the patient support table descending unexpectedly. The issue stems from a misalignment in a component after replacement. Health providers must stop using these devices 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 recall involves Philips CT systems labeled Ingenuity Core128 / Elite China, Model Number: 728324. These units were distributed worldwide, including in the US and multiple countries. The models affected include serial numbers ranging from 336817 to 337090.

The Hazard

The patient support table may descend to its lowest position unexpectedly due to a ball screw misalignment. This poses a high risk to patients during procedures.

Reported Incidents

There are no specific reported incidents or injuries associated with this recall at this time. The potential for injury remains due to the malfunction.

What to Do

Stop using the affected CT systems immediately. Follow the recall instructions provided by Philips. Contact Philips North America LLC or your healthcare provider for further instructions.

Contact Information

For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2602-2025. Philips North America LLC can be contacted for support.

Key Facts

  • 24 units recalled
  • Risk of unexpected descent
  • Affected model: Ingenuity Core128/Elite China, Model Number: 728324
  • No injuries reported yet
  • Immediate action required
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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Ingenuity Core128 / Elite China, Model Number: 728324
UDI-DI: 00884838059863
Serial Numbers: 336821
337127
336823
+15 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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