Recall Z-1066-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Electronics North America Corporation
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD
| Date | Oct 1, 2015 |
| Status | Terminated |
| Reason | Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed. |
| Root cause | Software design |
| Action | Philips sent a Field Safety Notice to all affected customers on October 1, 2015. The notice informs customers of the issue and the actions planned by Philips. Philips Field Service Engineers are to install Software R8.2.16.1 which addresses the issue. For further information or support concerning the issue, consignees should contact their local Philips Representative or call the Technical Support Line at 800-722-9377. |
| Quantity | 196 devices |
| Distribution | US Nationwide in the states of : AK, AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, UT, WI, WV and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, Aug 19, 2014 |