Z-2591-2020 Class II
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2020
- Initiation Date
- November 4, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 devices
Product Description
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.
Reason for Recall
The DAP meters were found to be outside of tolerance.
Distribution Pattern
US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
Code Information
Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.