Recall Z-1353-2023 ยท KPS System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
| Date | Apr 7, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| Reason | Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images. |
| Root cause | Software design |
| Action | On 03/01/2023, the firm sent an "Advisory Notification: Positron Emission Tomography and Computed Tomography System (PET/CT)" Letter via email to customers informing them that, the scatter correction may fail due to GPU (Graphic Processing Unit) memory access exception. The failure of the scatter correction could result in the failure of the PET image reconstruction. Customers are instructed to: 1. if the default PET image reconstruction fails with an error information of abnormal GPU status, but the reconstruction without either attenuation correction or scatter correction works successfull |
| Quantity | 47 systems (U.S. only) |
| Distribution | U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided. |
| FDA record | Open on fda.gov |