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.
- Company
- Shimadzu Medical Systems
- Recall Initiated
- November 4, 2019
- Recall Number
- Z-2591-2020
- Quantity
- 3 devices
- Firm Location
- Torrance, CA
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.
Lot / Code Info
Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.
Root Cause
Device Design
Action Taken
The firm issued a Field Safety Notice dated 11/5/2019 via email on 11/4/2019 describing the issue in "Digital Angiography System Trinias." The local representative was going to correct the device at the consignee locations.
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