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.
FDA Recall Z-2819-2020 · Posted None
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Recalling FirmShanghai United Imaging Healthcare Co., Ltd.
Recall StatusTerminated
Product CodeKPS
Date Initiated2020-03-26
Date Terminated2023-08-02
Product Quantity3
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.
Firm Action
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).
Root Cause
Software design
Distribution Pattern
US Nationwide distribution including in the state of TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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