Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System

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.

On 8/11/2026, correction notices were emailed to customers informing them that software will be released to resolve the software problem. Customers were asked to do the following: When using the Study Split function, follow the requirements below: 1) Temporarily disable the "Study Split" function. Navigate to the system configuration interface and uncheck the "Auto Study Split" option. 2) If the "Study Split" function is clinically necessary, open the system configuration interface and select "Split on PACS" instead of "Split on Local". 3) When "Auto study split" is checked, ensure that PACS (Picture Archiving and Communication System) is configured on site and auto-archive is enabled. 4) If images are found to be missing on the PA interface, immediately verify whether the corresponding image data exists in the PACS. a) If images exist in PACS: They can be retrieved from PACS for review. b) If images do not exist in PACS: Contact the firm's service engineer for assistance. For further questions, contact firm service engineer or call firm Customer Contact Center at (855) 221-1552 or 832-699-2799

• FDA enforcement recordOfficial FDA database entry for Z-3277-2026
• FDA 510(k) clearance · K181414The device's official FDA premarket clearance record
• FDA 510(k) clearance · K200016The device's official FDA premarket clearance record
• FDA device classification · JAKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Shanghai United Imaging Healthcare Co., Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.