FDA Device recall Z-2591-2020
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be use…
- FDA Device
- Class II
- completed
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be use… by Shimadzu Medical Systems, citing the DAP meters were found to be outside of tolerance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2591-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-11-04 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shimadzu Medical Systems |
| Distribution | US |
Product
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.
Identifiers
| code_info | Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2591-2020%22
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