Drug recall
Philips Medical System Allura Xper X-Ray Angiographic
FDA recall event 70011 · Class II · Philips Medical Systems, Inc.
Key facts
| Event ID | 70011 |
|---|---|
| Recall numbers | Z-1120-2015 |
| Recalling firm | Philips Medical Systems, Inc. |
| Product type | Devices |
| Products | Philips Medical System Allura Xper X-Ray Angiographic |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. |
| Initiation date | Jun 6, 2014 |
| Report date | Mar 11, 2015 |
| Termination date | Oct 15, 2021 |
| 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: