Recall Z-1708-2020 ยท KPS System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - 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 dis
| Date | Aug 26, 2019 |
| Status | Terminated |
| Reason | Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose. |
| Root cause | Software design |
| Action | On August 26, 2019, the firm emailed consignee an "Customer Notification" recall letter. In addition to informing consignees about the recall letter, the notification ask consignees to take the following actions: 1. If the user finds that PET reconstruction failing, the PET should be rescanned immediately to complete a new reconstruction. 2. If this occurs, please contact the UIH Solutions (UIHS) customer Contact Center at telephone numbers (855) 221-1552 (toll free) or (832) 699-2799 (direct) to report the issue. |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state 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 |