INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems — Class II medical device recall Z-0752-2016
Terminated recall by Toshiba American Medical Systems Inc, reported 2016-02-17, distributed nationwide. When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the l
| Recall number | Z-0752-2016 |
|---|---|
| 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 | 2015-08-14 |
| Classified | 2016-02-09 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| Reason classes | software |
| Serial numbers | AAA1492001, ACA1492002, W4B1432018, W4B1442020 |
Product
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Reason for recall
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
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-0752-2016. 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.