Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- Shanghai United Imaging Healthcare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT
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
- Product type
- Computed Tomography X-ray System
- Model numbers
- uCT 550 MD
- 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 uCT 550 MD is a computed tomography X-ray system used in medical imaging to diagnose and assess patients. Hospitals purchase such systems to perform high-resolution scans for a variety of conditions.
Why This Is Dangerous
A third-party outer cover can become trapped between the patient table and gantry, potentially interfering with table movement during scanning.
Industry Context
This recall is not described as part of a broader industry-wide pattern in the provided data.
Real-World Impact
Hospitals may need to suspend use of affected units, coordinate with the manufacturer for replacement or remediation, and manage imaging service disruptions while replacements are arranged.
Practical Guidance
How to identify if yours is affected
- Verify device model is uCT 550 MD
- Check serial numbers against the recalled list (353020–354017)
- Review the manufacturer recall notice for any additional identifiers
- Locate the device's label or specification plate for model and serial information
Where to find product info
Serial numbers and model are on the device label. Official recall notices are available on the FDA recall page and through UIH Technologies LLC.
What timeline to expect
Remediation or replacement will follow the manufacturer’s process. Typical timelines may vary, with potential weeks to months depending on hospital IT
If the manufacturer is unresponsive
- Escalate to facility administration and regulatory contacts
- File a report with FDA if the manufacturer is non-responsive
- Seek guidance from hospital risk management
How to prevent similar issues
- Do not modify or add third-party covers to the device
- Maintain strict adherence to medical device safety guidelines
- Ask vendors for compliant accessories that meet FDA requirements
Documentation advice
Document all communications with the manufacturer and hospital equipment managers. Save recall notices and serial lists. Photograph labels and serials for records.
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Product Details
Product: Computed Tomography X-ray System Model: uCT 550 MD Rx Only: Yes Quantity recalled: 22 units Sold to: Healthcare facilities in the United States Recall date: 2025-09-12 Manufacturer: Shanghai United Imaging Healthcare Co., Ltd. Distributor in US: UIH Technologies LLC Serial numbers: 353020, 353021, 353023, 353045, 353049, 354001, 354002, 354003, 354004, 354005, 354006, 354007, 354008, 354009, 354010, 354011, 354012, 354013, 354014, 354015, 354016, 354017 Country of origin: China Estimated price: Not disclosed
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model uCT 550 MD
- Hazard: third-party covers can trap and interfere with table movement
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Safety Guide
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