Lower riskMedical device recall · FDA · Published July 30, 2019
uDR 596i and uDR 592h X-ray Systems: Incorrect Spine Labeling May Cause Repeat Exposures
Shanghai United Imaging Healthcare recalls uDR 596i and uDR 592h X-ray systems due to reversed spine positioning labels, risking repeat patient exposures. Affected units have specific serial numbers and were sold with certain DI/GTIN codes.
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.
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Contact the company
📍Recalling firmShanghai United Imaging Healthcare Co., Ltd.No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, China
✎ GovInfoNow plain-language explainer
Shanghai United Imaging Healthcare is recalling two X-ray imaging systems (uDR 596i and uDR 592h) because their spine positioning labels are reversed. This could lead to incorrect images and repeat X-ray exposures for patients, which increases radiation risk. Read more at govinfonow.com/recall/67289-udr-596i-and-udr-592h-x-ray-systems-incorrect-spine.
“uDR 596i and uDR 592h X-ray Systems: Incorrect Spine Labeling May Cause Repeat Exposures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67289-udr-596i-and-udr-592h-x-ray-systems-incorrect-spine. Based on FDA recall #Z-1075-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1075-2022%22&limit=1).
Shanghai United Imaging Healthcare Co., Ltd. recalled four Digital Medical X-ray Imaging Systems, models uDR 596i and uDR 592h, due to reversed positioning labels that may cause incorrect image labeling and patient repeat exposure, the FDA said on July 30, 2019.
How to tell if you have it
Brand: Shanghai United Imaging Healthcare
Product: Digital Medical X-ray Imaging System
Models: uDR 596i, uDR 592h
UPC: 06971576833023
Serial Numbers: 270012, 270013, 270014, 270015
Quantity: 4 units
The hazard
The X-ray imaging system's positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine. This error causes the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
Context
GovInfoNow's records show Shanghai United Imaging Healthcare Co., Ltd. has 14 other recalls on record since August 26, 2019. Other recent recalls of similar products include Siemens LUMINOS Q.namix R X-Ray System Recall (December 29, 2025), GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026), and Siemens LUMINOS Q.namix T X-Ray System Recall (December 29, 2025).
How to tell if you have this one
Check for serial numbers 270012, 270013, 270014, or 270015 on the device. The product also has DI/GTIN code 06971576833023.
Brand
Shanghai United Imaging Healthcare
Product
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Labels
Look for the serial numbers 270012, 270013, 270014, or 270015 on the X-ray system.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3FDA terminated the recall
4Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1075-2022 (July 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1075-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.