Device product
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.
Z-2594-2021
Product summary
- Event
- Event 88521
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 system
- Official record key
device-enforcement:Z-2594-2021
Official wording
Reason: The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Code information: Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002
Distribution pattern: U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Derived failure modes
-
Unknown
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.