Toshiba Infinix-i X-Ray System — Class II medical device recall Z-0994-2013
Terminated recall by Toshiba American Medical Systems Inc, reported 2013-04-03, distributed nationwide. Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manua
| Recall number | Z-0994-2013 |
|---|---|
| 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 | 2012-11-08 |
| Classified | 2013-03-25 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 95 units |
| Reason classes | software |
Product
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Reason for recall
Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.
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-0994-2013. 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.