Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: Recalled by Shanghai United Imaging Healthcare Co., Ltd. Due to Two issues were identified with the stationary x-ray...
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
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk.
Quantity: 6 units
Why Was This Recalled?
Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.
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