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.
Reported: July 22, 2020 Initiated: November 4, 2019 #Z-2591-2020
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.
Details
- Recalling Firm
- Shimadzu Medical Systems
- Units Affected
- 3 devices
- Distribution
- US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
- Location
- Torrance, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shimadzu Medical Systems. Units affected: 3 devices.
Why was this product recalled? ▼
The DAP meters were found to be outside of tolerance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2020. Severity: Moderate. Recall number: Z-2591-2020.
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