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Medium risk Drugs & MedicationsClass II

Shanghai United Imaging Healthcare Co., Ltd. Recall

Computed Tomography X-ray System, Model: uCT ATLAS with software

Updated August 11, 2026

Shanghai United Imaging Healthcare Co., Ltd. is recalling Computed Tomography X-ray System, Model: uCT ATLAS with software. Hazard: 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.

Is the Shanghai United Imaging Healthcare Co., Ltd. recalled? Yes. This product was recalled by FDA on August 11, 2026. Details below.

What is recalled

Computed Tomography X-ray System, Model: uCT ATLAS with software

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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.

Brands affected

Shanghai United Imaging Healthcare Co., Ltd.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-3281-2026
Classification
Class II
Recalled
August 11, 2026
Read the official notice

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