INFX-8000V Interventional Angiography System — Class II medical device recall Z-1394-2015
Terminated recall by Toshiba American Medical Systems Inc, reported 2015-04-15, distributed nationwide. The table base rotational brake that holds the table top may not always be engaged when any force or side impa
| Recall number | Z-1394-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Toshiba American Medical Systems Inc, Tustin, CA, United States |
| Recall initiated | 2015-03-11 |
| Classified | 2015-04-06 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2015-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 28 units |
| Serial numbers | 99B1342133, 99B1342134, A4A13Z2001, A4B1472002, A6A1492002, AAA1492001, AAA14X2002, ACA1472001, ACA1492002, AHA1482001, U4A14X2001, U6A1472001, U7E1462009, UDE1352017, UEB1352004, UFD1362014, UFD13X2015, UFD13X2016, UFD1442017, UFD1452018, ULD1392013, ULD1412014, ULD1452015, ULD1452016, UPB1342004 and 4 more |
| Model numbers | 880B |
Product
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
Reason for recall
The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.
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-1394-2015. 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.