HIGH

Shanghai United Imaging Healthcare CT X-ray System uCT 550 MD Recall for 22 Units in 2025

Shanghai United Imaging Healthcare recalled 22 CT X-ray systems, including the uCT 550 MD, sold to healthcare facilities in the United States. A third-party outer cover can become trapped between the patient table and gantry, causing mechanical interference during table movement. Stop using the device and follow the manufacturer’s recall instructions immediately.

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

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

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

  1. Verify device model is uCT 550 MD
  2. Check serial numbers against the recalled list (353020–354017)
  3. Review the manufacturer recall notice for any additional identifiers
  4. 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.

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

  • 22 units recalled
  • Model uCT 550 MD
  • Rx Only
  • Serial numbers 353020–354017
  • Recall date 2025-09-12
  • Hazard: third-party covers can trap and interfere with table movement

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
GENERALPREGNANT
Injury Types
LACERATIONCRUSHINGOTHER

Product Details

Model Numbers
uCT 550 MD
Report Date
October 29, 2025
Recall Status
ACTIVE

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