HIGH

UIH Technologies Recalls X-ray System Over Mechanical Hazard

UIH Technologies recalled 8 units of its uCT 530 MD X-ray system on September 12, 2025. Third-party outer covers can trap between the patient table and gantry, causing mechanical interference. Healthcare providers and patients must stop using the device immediately.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brand
UIH Technologies
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact UIH Technologies LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled device is the Computed Tomography X-ray System, Model: uCT 530 MD. The recall affects 8 units distributed in the US and internationally. The recall was initiated on September 12, 2025.

The Hazard

Third-party outer covers can become trapped between the patient table and gantry. This poses a mechanical interference risk during table movement.

Reported Incidents

There are no reported injuries or incidents associated with this recall. The potential for interference presents a significant operational hazard.

What to Do

Stop using the device immediately. Follow recall instructions from the manufacturer. Contact UIH Technologies LLC or your healthcare provider for further guidance.

Contact Information

For more information, contact UIH Technologies LLC directly. Visit their website or refer to the recall notice on the FDA website.

Key Facts

  • 8 units recalled
  • Model: uCT 530 MD
  • Recall initiated on September 12, 2025
  • Potential mechanical interference hazard
  • No injuries reported

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Safety Assessment

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

Product Classification

Product TypeComputed Tomography X-ray System
Sold At
Multiple Retailers

Product Details

Model Numbers
Serial Numbers:
UDI: (01)06971576831012/ Serial Numbers: 300162 300163 300174 300176 304002 304003 304004 304006
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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