HIGH

Philips Recalls CT Systems Due to Fall Hazard

Philips recalled 81 IQon Spectral CT systems on August 13, 2025, due to a potential fall hazard. The patient support table may descend unexpectedly due to a ball screw misalignment. Healthcare providers and patients 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 recall affects IQon Spectral CT systems, Model Number: 728332. Serial numbers include 860088, 860023, 860077, and more. These systems were distributed worldwide, including the United States and 51 other countries.

The Hazard

The patient support table may descend unexpectedly to the lowest position, leading to potential injuries. This defect is attributed to a misalignment of the ball screw component.

Reported Incidents

As of now, there are no reported injuries related to this defect. The hazard presents a significant risk during patient procedures.

What to Do

Stop using the affected device immediately. Follow the manufacturer's recall instructions and contact Philips North America or your healthcare provider for further guidance.

Contact Information

For inquiries, reach Philips North America at their official website or the recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2601-2025.

Key Facts

  • 81 units recalled
  • Model Number: 728332
  • Potential fall hazard
  • Stop use immediately
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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: 728332
UDI-DI: 00884838059542
Serial Numbers: 860088
860023
860077
+15 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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