HIGH

UIH Technologies Recalls PET/CT System Over Mechanical Interference Risk

UIH Technologies recalled 3 units of its uMI 780 MD system on September 12, 2025. The device can trap third-party covers, causing table movement interference. Healthcare providers must stop using the device immediately and follow recall instructions.

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

Product Details

The recalled product is the Positron Emission Tomography and Computed Tomography System, Model: uMI 780 MD. The affected units include serial numbers 300072, 300082, and 300098. The devices were distributed in the U.S.

The Hazard

Third-party outer covers can become trapped between the patient table and gantry. This can lead to mechanical interference during table movement, posing a high risk to patient safety.

Reported Incidents

No specific incidents or injuries have been reported. However, the potential for mechanical interference presents a significant risk.

What to Do

Stop using the uMI 780 MD system immediately. Follow the recall instructions provided by UIH Technologies LLC. Contact the manufacturer or your healthcare provider for further instructions.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0224-2026.

Key Facts

  • Recalled model: uMI 780 MD
  • 3 units affected
  • Recall initiated on September 12, 2025
  • Mechanical interference risk due to outer covers
  • Contact UIH Technologies for instructions

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Safety Assessment

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

Product Classification

Product TypePositron Emission Tomography and Computed Tomography System
Sold At
Multiple Retailers

Product Details

Model Numbers
300072
300082
300098
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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