# K041949: Allura Xper FD10 - Pathway: 510(k) (Traditional) - Applicant: Philips Medical Systems North America Co. - Decided: Jul 30, 2004 after 10 days - Product code: IZI (System, X-Ray, Angiographic) - Device class: 2 - Regulation: 21 CFR 892.1600 - Recalls of this device: 48 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K890348 (1989). 8 ancestors in all. 64 later devices descend from it; 5 cite it directly. 10 of 73 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K031333: Philips Integris Allura Flat Detector Release 1.2, Philips Medical Systems North America, Inc. (2003) Summary page 1. ## Most influential descendants - K082907: IC-Pro System, Version 3.1.0.4 (2008), 36 descendants of its own - K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own - K102005: Allura Xper or Table Series (2010), 24 descendants of its own - K130638: Alluraclarity Xper FD Series X-Ray System (2013), 18 descendants of its own - K133292: Allura Xper FD; or Table (2014), 15 descendants of its own ## Recalls of this device - Sep 3, 2025 · Class II · Z-0001-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0002-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0003-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0004-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0005-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0006-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0007-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0008-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0009-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0010-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0011-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0012-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0014-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0015-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Sep 3, 2025 · Class II · Z-0013-2026: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. - Jan 13, 2025 · Class II · Z-1077-2025: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a fin - Feb 19, 2019 · Class II · Z-1140-2019: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This - Feb 19, 2019 · Class II · Z-1141-2019: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This - Jul 16, 2018 · Class II · Z-3228-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin - Jul 16, 2018 · Class II · Z-3225-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin - Jul 16, 2018 · Class II · Z-3229-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin - Jul 16, 2018 · Class II · Z-3227-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin - Jul 16, 2018 · Class II · Z-3230-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin - Jul 16, 2018 · Class II · Z-3226-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin - Mar 22, 2017 · Class II · Z-1822-2017: Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in th - Dec 9, 2016 · Class II · Z-1061-2017: System may lock up. - Dec 9, 2016 · Class II · Z-1062-2017: System may lock up. - Dec 1, 2016 · Class II · Z-0923-2017: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled. - Jul 6, 2015 · Class II · Z-0810-2016: The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position. - Feb 3, 2015 · Class II · Z-0347-2016: Monitor Ceiling Suspension system may fall - Feb 3, 2015 · Class II · Z-0349-2016: Monitor Ceiling Suspension system may fall - Feb 3, 2015 · Class II · Z-0354-2016: Monitor Ceiling Suspension system may fall - Feb 3, 2015 · Class II · Z-0353-2016: Monitor Ceiling Suspension system may fall - Feb 3, 2015 · Class II · Z-0348-2016: Monitor Ceiling Suspension system may fall - Feb 3, 2015 · Class II · Z-0350-2016: Monitor Ceiling Suspension system may fall - Feb 3, 2015 · Class II · Z-0351-2016: Monitor Ceiling Suspension system may fall - Feb 3, 2015 · Class II · Z-0352-2016: Monitor Ceiling Suspension system may fall - Feb 3, 2015 · Class II · Z-0346-2016: Monitor Ceiling Suspension system may fall - Sep 24, 2014 · Class II · Z-1280-2016: Loss of key image functionality due to a bent pedal of the Footswitch. - Jul 8, 2011 · Not classified · Z-2976-2011: System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period. - Nov 4, 2010 · Not classified · Z-1368-2011: Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal - Aug 21, 2008 · Not classified · Z-0124-2011: Due to a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. - Aug 21, 2008 · Not classified · Z-0125-2011: Potential for table and stand not to move due to a software error. - Mar 14, 2008 · Not classified · Z-1642-2008: Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation. - Aug 24, 2006 · Not classified · Z-0161-2007: Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned. - Aug 24, 2006 · Not classified · Z-0162-2007: Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned. - Oct 12, 2005 · Not classified · Z-0209-06: Potential for high voltage exposure involving the injector interface connector of patient support tables. - Oct 12, 2005 · Not classified · Z-0208-06: Potential for high voltage exposure involving the injector interface connector of patient support tables. ## Indications for use The Allura Xper FD10 is intended for cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems. Source page: https://510kreport.com/device/K041949 Methodology: https://510kreport.com/methodology