Class II recall Z-3285-2026: Shanghai United Imaging Healthcare Co., Ltd.
Class II recall Z-3285-2026: Shanghai United Imaging Healthcare Co., Ltd.: Shanghai United Imaging Healthcare Co., Ltd. Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 499 related FDAPulse records and the 5-column CSV export.
| 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 |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.
What is the FDAPulse record for Class II recall Z-3285-2026: Shanghai United Imaging Healthcare Co., Ltd.?
Class II device recall Z-3285-2026 by Shanghai United Imaging Healthcare Co., Ltd.: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function
How does Class II recall Z-3285-2026: Shanghai United Imaging Healthcare Co., Ltd. compare to other FDAPulse records?
It is 28 days old, still within a typical 45-day follow-up window.
Class II recall Z-3285-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3285-2026 | 2026-10-07 | |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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