Positron Emission Tomography and Computed Tomography System — Class II medical device recall Z-2819-2020
Terminated recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2020-08-26, distributed nationwide. In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfiel
| Recall number | Z-2819-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, N/A, China |
| Recall initiated | 2020-03-26 |
| Classified | 2020-08-18 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2023-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06971576832026 |
| Serial numbers | 200017, 200023, 200024 |
| Model numbers | 550 |
Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Reason for recall
In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2819-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.