Lower riskMedical device recall · FDA · Published February 27, 2020
uDR 596i X-Ray System Recall: Incorrect Positioning May Cause Misdiagnosis
Shanghai United Imaging Healthcare recalls uDR 596i X-Ray Systems with software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112 due to incorrect anatomical positioning and potential radiation exposure risks.
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.
Take action
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 uDR 596i X-Ray Systems because some position illustrations show incorrect anatomical positions, which can lead to misdiagnosis. Additionally, image stitching may cause loss of tag information, requiring extra radiation exposure for the patient. Read more at govinfonow.com/recall/65738-udr-596i-x-ray-system-recall-incorrect-positioning-may-cause.
“uDR 596i X-Ray System Recall: Incorrect Positioning May Cause Misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65738-udr-596i-x-ray-system-recall-incorrect-positioning-may-cause. Based on FDA recall #Z-2521-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2521-2020%22&limit=1).
The FDA announced on Feb. 27, 2020, that Shanghai United Imaging Healthcare Co., Ltd. recalled its uDR 596i Digital Medical X-Ray Imaging Systems due to software errors that may result in incorrect anatomical positioning or lost tag information, requiring additional patient radiation exposure. The agency terminated the Class II recall.
How to tell if you have it
uDR 596i Digital Medical X-Ray Imaging System
UPC: 06971576833023
Software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112
Serial numbers 270012, 270013, 270014, 270015, 270016 and 270017
The hazard
According to the FDA, some position illustrations in the patient exam interface show incorrect anatomical positions for standard of care. Additionally, where image stitching is used, left and right tag information may be lost. These issues require additional exposures, causing patients to receive more radiation.
Context
GovInfoNow's records show Shanghai United Imaging Healthcare Co., Ltd. has had 14 other recalls on record since July 30, 2019. Other recent recalls of similar products include a Positron Emission Tomography and Computed Tomography System recall (Aug. 11, 2026), uMI PET/CT Scanners software issue (March 1, 2023), and uMI 550 PET/CT System Wi-Fi interference recall (May 30, 2022). Other recent recalls of similar products include Siemens LUMINOS Q.namix R X-Ray System Recall (Dec. 29, 2025), Siemens LUMINOS Q.namix T X-Ray System Recall (Dec. 29, 2025), and Philips ALLURA Xper FD20 Biplane/Table Recall (March 3, 2026).
How to tell if you have this one
Check for model number uDR 596i with software versions R002.19.0-1.8402-690106 or R002.19.0.8648.690112. Serial numbers 270012-270017 are also affected.
Brand
Shanghai United Imaging Healthcare
Product
uDR 596i Digital Medical X-Ray Imaging System
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your uDR 596i system to see if it matches the affected versions R002.19.0-1.8402-690106 or R002.19.0.8648.690112.
Review Position Illustrations
Ensure the patient exam interface shows correct anatomical positioning for standard care procedures.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution including in the state of Texas.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2521-2020 (February 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2521-2020 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.