Recall Z-1067-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Model Number: 722008;
| Date | Jan 13, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| Reason | Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. |
| Root cause | Other |
| Action | On December 15, 2025, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: a. Affected systems may continue to be used in accordance with their Instructions for Use (IFU). b. Circulate this letter to all users so that they are aware of the issue. Keep this letter with the documentation of the system until Philips inspects and, where needed, corrects your system. c. Establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure. d. |
| Quantity | 18 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Ken |
| 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 |
| K161563 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Jul 29, 2016 |