Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Digital Medical X-ray Imaging System Recalled by Shanghai United Imaging Healthcare Co., Ltd. Due to X-ray imaging system positioning image and protocol label...
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
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Quantity: 4
Why Was This Recalled?
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
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