TRINIAS Digital Angiographic System intended to be used for cardiac… — Class II medical device recall Z-0197-2019
Terminated recall by Shimadzu Medical Systems Usa Com, reported 2018-10-31. Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during spec
| Recall number | Z-0197-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems Usa Com, Torrance, CA, United States |
| Recall initiated | 2018-06-15 |
| Classified | 2018-10-19 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2021-04-28 |
| Quantity | 1 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04540217049080 |
| Serial numbers | 41E58C977001 |
Product
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Reason for recall
Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
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-0197-2019. 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.