INFX-8000V Fluoroscopic X-Ray Systems — Class II medical device recall Z-0844-2018
Terminated recall by Toshiba American Medical Systems Inc, reported 2018-03-14. During an examination a device error occurred and the ceiling drive operation was disabled. It was found that
| Recall number | Z-0844-2018 |
|---|---|
| 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 | 2017-12-29 |
| Classified | 2018-03-02 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2023-11-29 |
| Quantity | 29 units |
| Serial numbers | A7B16Y2001, A8A1532001, A8B16Y2002, A9A1542001, A9A1582002, A9A1662003, A9A16X2004, AAA1492001, AAA14X2002, AAA1542003, AAA1632004, AAA1642005, AAA1692006, AAA1712007, ABB1627001, ACA1472001, ACA1492002, ACB1622003, ACB16Y2004, UEC1422013, UFD13X2015, UFD13X2016, UFD1442017, UFD1452018, UTC14Y2008 and 4 more |
Product
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
Reason for recall
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
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-0844-2018. 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.