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 The metal edge overlap of the mylar strip...
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; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Quantity: 3
Why Was This Recalled?
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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