Drug recall
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is…
FDA recall event 72325 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 72325 |
|---|---|
| Recall numbers | Z-1066-2016 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed. |
| Initiation date | Oct 1, 2015 |
| Report date | Mar 16, 2016 |
| Termination date | Oct 8, 2020 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1218950 |
At a glance
- 1–9 Products in this recall
- None 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: