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
- Unknown
- 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
- Computed Tomography X-ray System
- Model numbers
- uCT 530 MD, UDI: (01)06971576831012, Serial Numbers: 300162, Serial Numbers: 300163, Serial Numbers: 300174, Serial Numbers: 300176, Serial Numbers: 304002, Serial Numbers: 304003 +2 more
- 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
The uCT 530 MD is a computed tomography imaging system used in hospitals to produce diagnostic CT scans. It is designed for Rx-only use in clinical settings.
Why This Is Dangerous
A third-party outer cover can become trapped between the patient table and gantry, potentially causing mechanical interference during table movement and imaging procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Practical Guidance
How to identify if yours is affected
- 1) Confirm model is uCT 530 MD.
- 2) Check UDI is 01-06971576831012.
Where to find product info
Recall details at FDA enforcement page Z-0217-2026 and manufacturer recall notices. The UDI and serial numbers appear on the device label and in the recall notice.
What timeline to expect
UIH Technologies LLC will provide next steps and remediation timelines in the recall notice; timelines are not specified in the provided data.
If the manufacturer is unresponsive
- Escalate to hospital compliance or biosafety office.
- File a consumer safety complaint with the FDA if the vendor is unresponsive.
How to prevent similar issues
- Verify device recall status before installation or service contracts.
- Check UDI and serial numbers against recall lists during procurement and audits.
- Require recall readiness from vendors when acquiring medical imaging equipment.
Documentation advice
Keep copies of the recall letter, FDA notice, device labels showing model/UDI/serial numbers, and all communications with the manufacturer.
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Product Details
Brand: Shanghai United Imaging Healthcare Co., Ltd. (UIH Technologies LLC is the U.S. distributor) Product: Computed Tomography X-ray System, Model uCT 530 MD (Rx Only) Serial Numbers: 300162, 300163, 300174, 300176, 304002, 304003, 304004, 304006 UDI: (01)06971576831012 Quantity: 8 units Sold in the U.S.: Yes When sold: Unknown Price: Unknown Recall date: 2025-09-12 Recall status: ACTIVE
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model uCT 530 MD
- Status active (high hazard)
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Safety Guide
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