HIGH

UIH Technologies Recalls PET/CT System Over Mechanical Interference Risk

UIH Technologies recalled two units of the uEXPLORER MD system on September 12, 2025. Third-party covers can trap between the patient table and gantry, causing mechanical 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
Unknown
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 units include the uEXPLORER MD model with UDI: (01)06971576832040, Serial Number: F00002, and F00015. The devices were distributed in the U.S. and internationally.

The Hazard

The third-party outer covers can become trapped, leading to mechanical interference during table movement. This poses a high risk to patient safety and could result in injury.

Reported Incidents

There are no reported injuries or incidents associated with this recall. However, the potential for mechanical interference poses a significant risk.

What to Do

Immediately stop using the uEXPLORER MD system. Contact UIH Technologies LLC or your healthcare provider for further instructions.

Contact Information

For more information, visit UIH Technologies' website or call their customer service number. Recall instructions are also provided in a notification letter.

Key Facts

  • Two units recalled
  • Model: uEXPLORER MD
  • Recalled on September 12, 2025
  • Hazard: Mechanical interference
  • 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
Unknown

Product Details

Model Numbers
UDI: (01)06971576832040
Serial Number: F00002
F00015
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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