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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

United Imaging CT and PET/CT Systems Recalled for Mechanical Interference

Agency Publication Date: October 21, 2025
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Summary

UIH Technologies LLC has recalled approximately 149 units of various United Imaging Computed Tomography (CT) and PET/CT X-ray systems, including models uCT 530, uCT 550, uCT 760, uCT 780, uCT ATLAS, uEXPLORER, uMI 550, uMI 780, and uMI Panorama 35. The recall was initiated because third-party outer covers used on the devices can become trapped between the patient table and the gantry. This can cause mechanical interference and physical obstruction during table movement while the system is in use.

Risk

If an outer cover becomes trapped, it can interfere with the movement of the patient table, potentially causing unexpected mechanical behavior or stopping the table during an imaging procedure. This could lead to patient discomfort, delays in critical medical imaging, or minor physical injury due to obstructed equipment movement.

What You Should Do

  1. This recall affects United Imaging Computed Tomography (CT) and Positron Emission Tomography (PET/CT) systems, including models uCT 530, uCT 550, uCT 760, uCT 780, uCT ATLAS, uEXPLORER, uMI 550, uMI 780, and uMI Panorama 35.
  2. Check the device label on your system to identify the model and serial number. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device and avoid using third-party outer covers that could interfere with table movement.
  4. Contact UIH Technologies LLC or your distributor to arrange for a return, replacement, or corrective action as outlined in the firm's notification letter.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact UIH Technologies LLC or your distributor to arrange for a return, replacement, or correction.

Affected Products

Product: uCT 530 Computed Tomography X-ray Systemby United Imaging
Model / REF:
uCT 530
Serial Numbers:
300162
300163
300174
300176
304002
304003
304004
304006
UDI:
06971576831012

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Product: uCT 550 Computed Tomography X-ray Systemby United Imaging
Model / REF:
uCT 550
Serial Numbers:
353020
353021
353023
353045
353049
354001
354002
354003
354004
354005
354006
354007
354008
354009
354010
354011
354012
354013
354014
354015
354016
354017
UDI:
06971576831036

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Product: uCT 760 Computed Tomography X-ray Systemby United Imaging
Model / REF:
uCT 760
Serial Numbers:
600229
600232
600271
600282
604001
604002
604003
604004
604005
604006
604008
UDI:
06971576831043

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Product: uCT 780 Computed Tomography X-ray Systemby United Imaging
Model / REF:
uCT 780
Serial Numbers:
684001
684002
UDI:
06971576831050

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Product: uCT ATLAS Computed Tomography X-ray Systemby United Imaging
Model / REF:
uCT ATLAS
Serial Numbers:
863001
863002
UDI:
06971576831104

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Product: uEXPLORER Positron Emission Tomography and Computed Tomography Systemby United Imaging
Model / REF:
uEXPLORER
Serial Numbers:
F00002
F00015
UDI:
06971576832040

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Product: uMI 550 Positron Emission Tomography and Computed Tomography Systemby United Imaging
Model / REF:
uMI 550
Serial Numbers (95):
200017
200023
200024
200036
200045
200047
230002
230003
230004
230005
230006
230007
230008
230009
230011
230010
230012
230014
230013
200059
230015
230016
230017
230019
230020
230021
230022
230023
230024
230025
232001
200071
230026
230027
200072
230028
200074
230030
230029
200075
200076
230031
230032
230033
230034
230035
200079
200078
230037
230036
UDI:
06971576832026

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Product: uMI 780 Positron Emission Tomography and Computed Tomography Systemby United Imaging
Model / REF:
uMI 780
Serial Numbers:
300072
300082
300098
UDI:
06971576832033

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Product: uMI Panorama 35 Positron Emission Tomography and Computed Tomography Systemby United Imaging
Model / REF:
uMI Panorama 35
Serial Numbers:
11MI410003
11MI410004
11MI410005
20MI410001
UDI:
06971576832170

Shanghai United Imaging Healthcare Co., Ltd.; MD, Rx Only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97668
Status: Active
Manufacturer: UIH Technologies LLC
Sold By: Authorized Medical Equipment Distributors; Healthcare Facilities; Hospitals
Manufactured In: United States, China
Units Affected: 9 products (8 units; 22 units; 11 units; 2 units; 2 units; 2 UNITS; 95 units; 3 units; 4 unit)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.