Use cautionMedical device recall · FDA · Published January 25, 2021
Shanghai United Imaging Healthcare X-ray System uDR 596i Recall: Uncommanded Motion Risk
Shanghai United Imaging Healthcare recalls uDR 596i X-ray systems with potential for uncommanded motion causing patient collisions. Affected units have specific serial numbers. Contact for remedy.
There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
Take action
Contact the company
📍Recalling firmShanghai United Imaging Healthcare Co., Ltd.No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, China
“Shanghai United Imaging Healthcare X-ray System uDR 596i Recall: Uncommanded Motion Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63354-shanghai-united-imaging-healthcare-x-ray-system-udr-596i-recall. Based on FDA recall #Z-1160-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1160-2021%22&limit=1).
The FDA announced on Jan. 25, 2021, that Shanghai United Imaging Healthcare Co., Ltd. is recalling six Digitial Medica X-ray Imagining Systems due to a potential uncommanded motion of the X-ray tube head that could collide with patients. The recall was voluntary and has been terminated.
Serial Numbers: 270012, 270013, 270014, 270015, 270016, 270017
Distribution: US Nationwide distribution in the state of TX
The hazard
The X-ray tube head (Touch screen interface) may perform an uncommanded motion. This could result in a collision with the patient.
Context
GovInfoNow's records show Shanghai United Imaging Healthcare Co., Ltd. has 14 other recalls on record since July 30, 2019. Other recent recalls of similar products include GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025), and GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026).
How to tell if you have this one
Check for serial numbers 270012 through 270017 on the uDR 596i X-ray system. The product is intended for use by trained medical staff in diagnostic imaging.
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-1160-2021 (January 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1160-2021 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.