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
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
- Shanghai United Imaging Healthcare, UIH Technologies
- Product type
- PET/CT System
- Model numbers
- uMI Panorama 35 MD, UDI: (01)06971576832170
- Sold at
- Multiple Retailers
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
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
- Verify model is uMI Panorama 35 MD.
- Check for the UDI (01)06971576832170 on the device label.
- 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.
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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
- PET/CT system model: uMI Panorama 35 MD
- Hazard: outer covers can trap between table and gantry during movement
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Safety Guide
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