Toshiba Infinix X-Ray Interventional System INFX-8000V/UU — Class II medical device recall Z-1714-2014
Terminated recall by Toshiba American Medical Systems Inc, reported 2014-06-11, distributed nationwide. Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed an
| Recall number | Z-1714-2014 |
|---|---|
| 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 | 2014-05-12 |
| Classified | 2014-06-04 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Serial numbers | A4A113Z2001, ULD1412014, UUC13Z2011 |
Product
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Reason for recall
Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
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-1714-2014. 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.