Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Computed Tomography X-ray System, Model: uCT 530 with software
Shanghai United Imaging Healthcare Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shanghai United Imaging Healthcare Co., Ltd. · No. 2258 Chengbei Rd, Jiading Ind. · Shanghai · N/A
Is this the product you have?
- Computed Tomography X-ray System
- ModeluCT 530 with software
- Lot codes and dates
- UDI-DI06971576831012
- Serial Numbers/Software
300174/R001.19.5.1839204-Re3300SP1H1_P4304006/R001.17.6.1607336-Re3100SP4304007/R001.19.4.1810621-Re3300SP1H1_P3304008/R001.19.4.1810621-Re3300SP1H1_P3
- Amount recalled
- 4
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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