uMI recallZ-2819-2020 · Shanghai United Imaging Healthcare Co., Ltd. · initiated Mar 26, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Shanghai United Imaging Healthcare Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
On March 26, 2020, Customer Notification Letters were emailed to customers. The recalling firm has released a software hotfix to address the issue for the affected products. The corrective action of on-site upgrade will be provided free of charge. For further questions, feel free to contact the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct).
Recall details
- Recall number
- Z-2819-2020
- Status
- Terminated
- Initiated by the company
- Mar 26, 2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 3
- Product code
- KPS
- FDA submissions
- K182237
- Distribution
- US Nationwide distribution including in the state of TX.
Product description
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.
Code information (models, lots, serial numbers)
UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- uMI uMI 550Shanghai United Imaging Healthcare Co., Ltd. · System, Tomography, Computed, Emission6 recalls0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K182237 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- uMI uMI 550Shanghai United Imaging Healthcare Co., Ltd. · System, Tomography, Computed, Emission2 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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