Trinias DAP Meter — Class II medical device recall Z-2591-2020
Completed recall by Shimadzu Medical Systems, reported 2020-07-22, distributed nationwide. The DAP meters were found to be outside of tolerance.
| Recall number | Z-2591-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2019-11-04 |
| Classified | 2020-07-14 |
| Reported by FDA | 2020-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 3 devices |
| Serial numbers | LR051A58B027, LR051A58B028, LR051A58B029 |
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 for recall
The DAP meters were found to be outside of tolerance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2591-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.