Recall Z-2800-2020 ยท JAK System, X-Ray, Tomography, Computed
Shanghai United Imaging Healthcare Co., Ltd.
uMI 550 PET/CT Diagnostic Imaging System - 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 neurology.
| Date | Aug 13, 2020 (initiated Jul 16, 2020) |
| Status | Terminated |
| Reason | 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036) |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction Letters regarding the uEXPLORER and uMI 550 were sent to customers on July 16, 2020 via email. Customers were informed that the firm had received complaints on these products and advised customers to take the following actions if problems were observed: 1. if image artifacts occur, reboot the system and continue the reconstruction. If necessary, repeat the scan which will result in an additional dose of radiation and the possible need for additional contrast medium. 2. If scout scanning is unexpectedly interrupted, try repeating the scout. This will result |
| Quantity | 4 units |
| Distribution | US Nationwide distribution including in the state of Texas. |
| 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 |