TRINIAS for diagnostic imaging and interventional procedures in… — Class II medical device recall Z-0864-2019
Terminated recall by Shimadzu Medical Systems Usa Com, reported 2019-02-27, distributed in CT, FL, IL, LA, MS, MT, OH, SC…. Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the fir
| Recall number | Z-0864-2019 |
|---|---|
| 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 | 2019-01-14 |
| Classified | 2019-02-21 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2021-04-30 |
| Distributed | CT, FL, IL, LA, MS, MT, OH, SC, TX |
| Quantity | 13 units |
| Serial numbers | 41B247746001, 41B24774C001, 41E58C757001, 41E58C765001, 41E58C766001, 41E58C769001, 41E58C76B001, 41E58C773001, 41E58C775001, 41E58C776001, 41E58C777001, 41E58C977001, 41EFCD77C001 |
Product
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Reason for recall
Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
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-0864-2019. 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.