Recall Z-2819-2020 ยท KPS System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co., Ltd.
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 neu
| Date | Mar 26, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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). |
| Quantity | 3 |
| Distribution | US Nationwide distribution including in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182237 | uMI 550 PET/CT System Shanghai United Imaging Healthcare Co., Ltd., Oct 12, 2018 |