Drug recall
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
FDA recall event 73078 · Class II · Toshiba American Medical Systems Inc
Key facts
| Event ID | 73078 |
|---|---|
| Recall numbers | Z-0752-2016 |
| Recalling firm | Toshiba American Medical Systems Inc |
| Product type | Devices |
| Products | INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 14, 2015 |
| Report date | Feb 17, 2016 |
| Termination date | May 18, 2016 |
| City | Tustin |
| State | CA |
| Country | United States |
| FEI number | 2020563 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: