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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- UIH Technologies, Shanghai United Imaging Healthcare Co., Ltd.
- Product type
- Positron Emission Tomography and Computed Tomography System (PET/CT)
- Model numbers
- uMI 780 MD
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify device model uMI 780 MD, Rx Only
- Check distributor and serial number against recall list
- 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
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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
- Hazard level HIGH
- Model uMI 780 MD, Rx Only
- US distribution only
- No injuries reported in notice
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Safety Guide
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