Drug recall
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional…
FDA recall event 79770 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 79770 |
|---|---|
| Recall numbers | Z-1589-2018 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself. |
| Initiation date | Mar 14, 2018 |
| Report date | May 9, 2018 |
| Termination date | Apr 29, 2024 |
| 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: