Device product
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
Z-2591-2020
Product summary
- Event
- Event 85416
- Status
- Completed
- Classification
- Class II
- Quantity
- 3 devices
- Official record key
device-enforcement:Z-2591-2020
Official wording
Reason: The DAP meters were found to be outside of tolerance.
Code information: Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.
Distribution pattern: US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
Derived failure modes
-
Unknown
The DAP meters were found to be outside of tolerance.