Recall Z-2412-2026 · OWB Interventional Fluoroscopic X-Ray System

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD2

Date	Jun 16, 2026 (initiated May 18, 2026)
Status	Open, Classified
Reason	Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Root cause	Radiation Control for Health and Safety Act
Action	Philips will send a customer notification dated May 18, 2026 to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and replace the hand switch with a new design hand switch.
Distribution	US and ROW.
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