uCT recallZ-2472-2020 · Shanghai United Imaging Healthcare Co., Ltd. · initiated May 8, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Shanghai United Imaging Healthcare Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
FDA root cause category: Software design
What the company is doing
The firm sent letters to their customers by email on 5-22-2020. The letter informs customers of the two potential safety issues with the device, and notes that these problems may cause image artifacts and scanning workflow interruptions. Risks to patient health are noted to include the possible need to rescan the patient resulting in an additional radiation dose and the possible need for additional contrast medium. Customers were informed that United Imaging has released a field update for the uCT 530 to address the issues. If customers observe image artifacts, they are requested to reboot the system and continue the reconstruction. If the scout scanning is interrupted, customers are instructed to try repeating the scout scanning. If problems persist, customers should contact their United Imaging service support team or call the United Imaging Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct).
Recall details
- Recall number
- Z-2472-2020
- Status
- Open, Classified
- Initiated by the company
- May 8, 2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 4 units
- Product code
- JAK
- FDA submissions
- K181414
- Distribution
- Distributed to Texas.
Product description
uCT 530 Computed Tomography X-Ray System
Code information (models, lots, serial numbers)
Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- uCT uCT 530Shanghai United Imaging Healthcare Co., Ltd. · System, X-Ray, Tomography, Computed3 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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