# Class II recall Z-3285-2026: Shanghai United Imaging Healthcare Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3285-2026 |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ. |
| Recall initiated | 2026-08-11 |
| Reported | 2026-10-07 |
| Firm location | Shanghai, China |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3285-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.