HIGH

UIH Technologies PET/CT System Recall Affects 3 Units Over Gantry Interference Risk (2025)

UIH Technologies recalls 3 units of Shanghai United Imaging Healthcare uMI 780 PET/CT systems after a third-party outer cover can trap between the patient table and gantry. The issue can obstruct table movement. Hospitals are urged to stop using the devices and follow recall instructions.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
UIH Technologies, Shanghai United Imaging Healthcare Co., Ltd.
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL, PREGNANT, PETS

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

PET/CT systems merge functional imaging with CT for diagnostic purposes. They are used in hospitals for oncology and other imaging needs.

Why This Is Dangerous

A third-party outer cover can become trapped between table and gantry, interfering with table movement and potentially affecting imaging procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Direct impact on hospital workflows and patient safety during imaging; no injuries reported in the notice.

Practical Guidance

How to identify if yours is affected

  1. Verify device model uMI 780 MD, Rx Only
  2. Check distributor and serial number against recall list
  3. Confirm unit count matches 3 units in US distribution

Where to find product info

FDA recall page Z-0224-2026, manufacturer recall letters

What timeline to expect

Remedy and next steps will be provided by manufacturer; follow-up actions may include repair or replacement within weeks to months

If the manufacturer is unresponsive

  • Escalate to hospital's compliance office
  • Contact FDA for guidance if manufacturer is unresponsive
  • Seek device recall assistance from patient safety organizations

How to prevent similar issues

  • Ensure third-party covers are certified for MRI/CT gear
  • Coordinate with biomedical engineering before any modification
  • Maintain updated recall communications from FDA
  • Document all actions and correspondence

Documentation advice

Keep recall notice, serial numbers, service reports, and any replacement paperwork

Product Details

Model: uMI 780 MD, Rx Only. Quantity: 3 units. Distribution: US only. Recall date: 2025-09-12. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd. Recall status: ACTIVE. Notification method: Letter. 3 units affected in the US market.

Reported Incidents

No specific injuries or incidents are detailed in the recall notice. Hazard classified as HIGH risk.

Key Facts

  • 3 units recalled
  • Recall date 2025-09-12
  • Hazard level HIGH
  • Model uMI 780 MD, Rx Only
  • US distribution only
  • No injuries reported in notice

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
GENERALPREGNANTPETS
Injury Types
ELECTRICALLACERATIONOTHER

Product Classification

Product Details

Model Numbers
uMI 780 MD
Report Date
October 29, 2025
Recall Status
ACTIVE

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