Shanghai United Imaging Healthcare Co., Ltd.: System, Tomography, Computed, Emission

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.

Tags

FDA recall, medical device, class 2, Radiology, Software design, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISA 3: Information Systems Acquisition, Development and Implementation; CISA 5: Protection of Information Assets

Source record id

Z-3287-2026

First seen by InfoSec Signals

10/9/2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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