FDA recall Z-2591-2020

Shimadzu Medical Systems · Class II · 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.

Reason for recall

The DAP meters were found to be outside of tolerance.

Distribution

US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.

Key facts

Status
Completed
Initiation date
2019-11-04
Report date
2020-07-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2020