FDA Device recall Z-0844-2018
INFX-8000V Fluoroscopic X-Ray Systems
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of INFX-8000V Fluoroscopic X-Ray Systems by Toshiba American Medical Systems, citing 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 loose….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0844-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-29 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | n/a |
Product
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
Reason
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.
Identifiers
| code_info | Serial Numbers: UFD13X2015, UFD13X2016, UUC13Z2011, UEC1422013, UFD1442017, UFD1452018, AAA1642005, UUC1452012, UTC14Y2…Serial Numbers: UFD13X2015, UFD13X2016, UUC13Z2011, UEC1422013, UFD1442017, UFD1452018, AAA1642005, UUC1452012, UTC14Y2008, ACA1472001, ACA1492002, AAA1492001, AAA14X2002, A8A1532001, A9A1542001, AAA1542003, A9A1582002, ABB1627001, ACB1622003, A9A1662003, AAA1692006, A9A16X2004, A8B16Y2002, A7B16Y2001, ACB16Y2004, AAA1632004, AAA1712007, W4B1622031, W4B14Y2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0844-2018%22
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