Recall Z-2591-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Shimadzu Medical Systems
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.
| Date | Nov 4, 2019 |
| Status | Completed |
| Reason | The DAP meters were found to be outside of tolerance. |
| Root cause | Device Design |
| 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. |
| Quantity | 3 devices |
| Distribution | US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123508 | TRINIAS Shimadzu Corporation, Feb 26, 2014 |