BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system… — Class II medical device recall Z-0959-2019
Terminated recall by Shimadzu Medical Systems Usa Com, reported 2019-03-06, distributed nationwide. Normal operation of the device is to power up the device in the morning, register the first patient, and then
| Recall number | Z-0959-2019 |
|---|---|
| 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 | 2019-02-26 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2024-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| Serial numbers | 0161Q82302, 0161Q83102, 0161Q84501, 0261Q80503, 0261Q80804, 3M7A16A1A001, 40AD58C4B001, 40AD58C55001 |
Product
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.
Reason for recall
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.
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-0959-2019. 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.