FDA-Device2020-07-22Class II
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.
Shimadzu Medical Systems
Hazard
The DAP meters were found to be outside of tolerance.
Sold states
US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
Affected count
3 devices
Manufactured in
20101 S Vermont Ave, N/A, Torrance, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2020Don't want to check this manually?
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