Drug recall
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product…
FDA recall event 79099 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 79099 |
|---|---|
| Recall numbers | Z-0716-2018 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This… |
| Initiation date | Jan 4, 2018 |
| Report date | Mar 7, 2018 |
| Termination date | Oct 9, 2019 |
| 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: