FDA Device recall Z-2819-2020
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is inte…
- FDA Device
- Class II
- terminated
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is inte… by Shanghai United Imaging Healthcare, citing 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 tracki….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2819-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-26 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2819-2020%22
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