Recall Z-2504-2025 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 7
| Date | Sep 3, 2025 (initiated Aug 1, 2025) |
| Status | Open, Classified |
| Reason | Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. |
| Root cause | Under Investigation by firm |
| Action | Philips began notifying consignees on about 08/01/2025 via letter. Consignees were instructed to notify all applicable personnel, notify customers if the units have been transferred or distributed, maintain the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system, and to complete and return the response form. Philips will be inspecting affected Nehalem Flexvision-2 PCs and installing the air baffle if it is confirmed that this component is missing. Philips expects to start the implementation of this action in affected devices by Q4 202 |
| Quantity | 192 untis |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, HI, ID, IL, KS, KY, LA, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI, WV and the countries of Argentina, Austria, Australia, Belgium, Switzerland, Chile, China, Colombia, Czechia, Germany, Egypt, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102005 | ALLURA XPER OR TABLE SERIES Philips Medical Systems North America, Inc., Aug 9, 2010 |
| K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Philips Medical Systems Nederland B.V., Jun 28, 2013 |
| K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES Philips Medical Systems Nederland B.V., May 21, 2013 |
| K133292 | ALLURA XPER FD; OR TABLE Philips Medical Systems Nederland B.V., Mar 5, 2014 |
| K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, Aug 19, 2014 |