Drug recall
Allura CV20, system code 722031
FDA recall event 84756 · Class II · Philips North America, LLC
Key facts
| Event ID | 84756 |
|---|---|
| Recall numbers | Z-1486-2020, Z-1487-2020, Z-1488-2020, Z-1489-2020, Z-1490-2020, Z-1491-2020, Z-1492-2020, Z-1493-2020, Z-1494-2020 |
| Recalling firm | Philips North America, LLC |
| Product type | Devices |
| Products | Allura CV20, system code 722031, Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an…, Cardio Vascular-Allura Centron, system code 722400, Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044), Integris Allura 9, system codes 722018 722021 and 4 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible. |
| Initiation date | Dec 30, 2019 |
| Report date | Mar 25, 2020 |
| Termination date | Nov 17, 2022 |
| 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: