FDA Recall
Completed
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.
Recall: Z-2591-2020
·
Initiated November 4, 2019
Recall
- Recall Number
- Z-2591-2020
- Event Number
- 85416
- Firm
- Shimadzu Medical Systems
- FEI Number
- 1000125362
- Product Code
- OWB
- Status
- Completed
- Root Cause
- Device Design
- Initiated
- November 4, 2019
- Address
- 20101 S Vermont Ave, Torrance, CA, 90502-1328
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
The DAP meters were found to be outside of tolerance.
Action
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.
Distribution
US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
Quantity
3 devices