HIGH

Philips Recalls CT Systems Over Risk of Unexpected Descent

Philips recalled three Ingenuity CT Family systems on August 13, 2025, due to a hazard that could lead to sudden descent. The issue stems from a ball screw misalignment affecting the patient support table. Users should stop using the devices immediately and follow recall 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 involves Ingenuity CT Family systems, Model Number 728325. The affected serial numbers are 338014, 338028, and 338019. These devices were distributed worldwide, including the US and several other countries.

The Hazard

The patient support table may descend unexpectedly to the lowest position, posing a risk of injury. This issue arises from a component misalignment after replacement.

Reported Incidents

No injuries or incidents have been reported related to this recall. The risk remains significant due to the potential for unexpected descents.

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, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2603-2025.

Key Facts

  • Recall date: August 13, 2025
  • Status: Active
  • Quantity recalled: 3 units
  • Hazard classification: Class II
  • Affected serial numbers: 338014, 338028, 338019
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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Model Number: 728325
Serial Numbers: 338014
338028
338019
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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