Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Computed Tomography X-ray System Recalled by Shanghai United Imaging Healthcare Co., Ltd. Due to Two issues were identified with the computed tomography...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Shanghai United Imaging Healthcare Co., Ltd. directly.
Affected Products
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).
Quantity: 3
Why Was This 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.
Where Was This Sold?
This product was distributed to 1 state: TX
About Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report