Recall Z-0448-2021 ยท KPS System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: 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.
| Date | Aug 5, 2020 |
| Status | Open, Classified |
| Reason | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation. |
| Root cause | Software design |
| Action | The firm sent notification letters via email to distributorsThe firm's consignee hand delivered a written Field Safety Notification to end-users on June 11, 2020 to inform them that the delay time displayed on the DDP can be incorrect for a timed scan such as a multi-phase contrast scan. The DDP is located on the gantry in the scan room. If the operator enters the scan room to perform any multi-phase contrast scan and refers to the incorrect delay time displayed on the DDP, he or she may not be able to leave the scan room before the scan starts, and as a result may receive unnecessary radiatio |
| Quantity | 9 |
| 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 |