Drug recall
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and…
FDA recall event 72599 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 72599 |
|---|---|
| Recall numbers | Z-0702-2016, Z-0703-2016, Z-0704-2016, Z-0705-2016, Z-0706-2016, Z-0707-2016, Z-0708-2016, Z-0709-2016, Z-0710-2016, Z-0711-2016, Z-0712-2016, Z-0713-2016 and 17 more |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are…, Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent…, Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional…, Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent…, Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral… and 24 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. |
| Initiation date | Nov 3, 2015 |
| Report date | Feb 10, 2016 |
| Termination date | Sep 15, 2020 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1218950 |
At a glance
- 10–99 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: