Recall Z-3285-2026— Shanghai United Imaging Healthcare Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2026-08-11. It names 2 FDA 510(k) clearances: K241585, K231572. Product: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software. Reason: 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..
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-11
- Firm location
- Shanghai, China
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.