Device product
uEXPLORER 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.
Z-2799-2020
Product summary
- Event
- Event 85948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit distributed to Texas
- Official record key
device-enforcement:Z-2799-2020
Official wording
Reason: 1) 1) Potential intermittent issue may cause image data problems, may lead to 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.
Code information: Serial No. F00002; GTIN 06971576832040
Distribution pattern: US Nationwide distribution including in the state of Texas.
Derived failure modes
-
Unknown
1) 1) Potential intermittent issue may cause image data problems, may lead to 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.