uDR 596i Digital Medical X-Ray Imaging System - Product… recallZ-2521-2020 · Shanghai United Imaging Healthcare Co., Ltd. · initiated Feb 27, 2020
Terminated
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 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.
FDA root cause category: Software design
What the company is doing
The firm sent a Customer Notification Letter by email on February 27, 2020. The letter included identification of the serial numbers of devices affected by this issue. The firm's direct customers were instructed to identify users of the affected systems which have been installed. Customers were informed that they should not refer to illustrations showing the incorrect anatomical position for the standard of care, and that the impacted systems will be immediately remedied with a software hotfix on R002.19.0-4.8648-690113 software version via field software update. Customers with questions were instructed to call (855) 221-1552 (toll free) or (832) 699-2799 (direct).
Recall details
- Recall number
- Z-2521-2020
- Status
- Terminated
- Initiated by the company
- Feb 27, 2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 6 units
- Product code
- KPR
- FDA submissions
- K181413
- Distribution
- US Nationwide distribution including in the state of Texas.
Product description
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.
Code information (models, lots, serial numbers)
Model Number uDR 596i with software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112. Serial numbers: 270012, 270013, 270014, 270015, 270016 and 270017. UDI numbers: (01)06971576833023(240)88000093(21)270012; (01)06971576833023(240)88000093(21)270013; (01)06971576833023(240)88000093(21)270014; (01)06971576833023(240)88000093(21)270015; XXX; and XXX.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- uDR uDR 596iShanghai United Imaging Healthcare Co., Ltd. · Solid State X-Ray Imager (Flat Panel/Digital Imager)2 recalls0 reports
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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