Recall Z-2594-2021 ยท KPS System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT System - 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 2, 2021 |
| Status | Open, Classified |
| Reason | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. |
| Root cause | Device Design |
| Action | On 08/02/2021, the Firm emailed to its customer an "Advisory Notification" informing them of a potential safety-relevant issue in which the EXAM acquisition workflow could occasionally freeze after canceling the PET scan. The issue and the sequence of events leading to this occurrence are as follow: During a myocardial perfusion scan procedure, the follow steps could lead to the EXAM acquisition workflow to occasionally freeze- 1. Selecting the myocardial perfusion scan procedure and entering EXAM. 2. Finishing the CT scout and helical/cine scan. 3. Starting the PET scan. 4. Canceling the cur |
| Quantity | 1 system |
| Distribution | U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI. |
| FDA record | Open on fda.gov |