HIGH

Shanghai United Imaging Healthcare uMI Panorama 35 MD PET/CT System Recalled for 4 Units (2025)

UIH Technologies LLC is recalling 4 Shanghai United Imaging Healthcare uMI Panorama 35 MD PET/CT systems sold in the United States. A third-party outer cover can become trapped between the patient table and gantry during table movement. Hospitals and clinics should stop using the devices and follow the manufacturer’s recall instructions.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
Shanghai United Imaging Healthcare, 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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About This Product

The uMI Panorama 35 MD PET/CT System is a hybrid imaging device used in hospitals to produce fused PET and CT images for diagnostic purposes.

Why This Is Dangerous

A third-party outer cover can become trapped between the patient table and gantry, leading to mechanical interference during movement and potential procedure disruption.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

The hazard can disrupt imaging workflows and potentially affect patient safety if the device is operated with the cover trapped.

Practical Guidance

How to identify if yours is affected

  1. Verify model is uMI Panorama 35 MD.
  2. Check for the UDI (01)06971576832170 on the device label.
  3. Review serial numbers 11MI410003, 11MI410004, 11MI410005, 20MI410001 to confirm involvement.

Where to find product info

Look for the recall letter and the device label showing model, UDI, and serial numbers.

What timeline to expect

Remediation timeline not specified by the manufacturer; expect communications by letter and facility coordination.

If the manufacturer is unresponsive

  • Escalate to hospital risk management and the device manufacturer.
  • Consult the FDA recall contact if the facility cannot obtain timely instructions.

How to prevent similar issues

  • Use only manufacturer-approved covers and accessories.
  • Monitor for recall notices and promptly implement manufacturer guidance.
  • Maintain a robust device-tracking system to identify affected units quickly.

Documentation advice

Keep the recall letter, document serial numbers and UDI, save all correspondence, and record remediation steps taken.

Product Details

Model numbers: uMI Panorama 35 MD UDI: (01)06971576832170 Serial numbers: 11MI410003, 11MI410004, 11MI410005, 20MI410001 Where sold: United States and international distribution When sold: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 4 units affected
  • PET/CT system model: uMI Panorama 35 MD
  • UDI: (01)06971576832170
  • Serial numbers: 11MI410003, 11MI410004, 11MI410005, 20MI410001
  • Hazard: outer covers can trap between table and gantry during movement

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Details

Model Numbers
uMI Panorama 35 MD
UDI: (01)06971576832170
Report Date
October 29, 2025
Recall Status
ACTIVE

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