# K141979: Allura Xper FD Series / Allura Xper or Table Series - Pathway: 510(k) (Special) - Applicant: Philips Medical Systems Netherland BV - Decided: Aug 19, 2014 after 29 days - Product code: OWB (Interventional Fluoroscopic X-Ray System) - Device class: 2 - Regulation: 21 CFR 892.1650 - Recalls of this device: 81 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 11 generations back to K801623 (1980). 52 ancestors in all. 13 later devices descend from it; 3 cite it directly. 5 of 66 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K133292: Allura Xper FD; or Table, Philips Medical Systems Nederland B.V. (2014) Summary page 4. ## Most influential descendants - K162148: Allura Xper R9 (2016), 8 descendants of its own - K163715: Allura Xper R9 (2017), 7 descendants of its own - K172822: Azurion series R1.2 (2017), 6 descendants of its own - K181830: Azurion R2.0 (2018), 5 descendants of its own - K200917: Azurion R2.1 (2020), 4 descendants of its own ## Recalls of this device - Jun 29, 2026 · Class II · Z-2928-2026: Firmware issue potentially leading to loss of geometry movements. - Jun 17, 2026 · Class II · Z-2891-2026: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. - Jun 17, 2026 · Class II · Z-2893-2026: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. - May 18, 2026 · Class II · Z-2412-2026: 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 - Apr 30, 2026 · Class II · Z-2258-2026: It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on - Apr 30, 2026 · Class II · Z-2259-2026: It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on - Dec 15, 2025 · Class II · Z-1062-2026: 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 - Dec 15, 2025 · Class II · Z-1071-2026: 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 - Dec 15, 2025 · Class II · Z-1075-2026: 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 - Dec 15, 2025 · Class II · Z-1064-2026: 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 - Dec 15, 2025 · Class II · Z-1076-2026: 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 - Dec 15, 2025 · Class II · Z-1070-2026: 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 - Dec 15, 2025 · Class II · Z-1073-2026: 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 - Dec 15, 2025 · Class II · Z-1066-2026: 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 - Dec 15, 2025 · Class II · Z-1063-2026: 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 - Dec 15, 2025 · Class II · Z-1068-2026: 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 - Dec 15, 2025 · Class II · Z-1067-2026: 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 - Dec 15, 2025 · Class II · Z-1069-2026: 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 - Dec 15, 2025 · Class II · Z-1072-2026: 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 - Dec 15, 2025 · Class II · Z-1074-2026: 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 - Dec 15, 2025 · Class II · Z-1065-2026: 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 - Dec 15, 2025 · Class II · Z-1077-2026: 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 - Sep 3, 2025 · Class II · Z-2624-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2634-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2626-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2629-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2625-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2635-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2628-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2627-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2633-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2623-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2631-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2632-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Sep 3, 2025 · Class II · Z-2630-2025: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movem - Aug 1, 2025 · Class II · Z-2504-2025: Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. - Aug 1, 2025 · Class II · Z-2503-2025: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost. - Jun 30, 2025 · Class II · Z-2189-2025: Potential for temporary loss of imaging (X-ray) functionality due to software issue. - Jan 13, 2025 · Class II · Z-1080-2025: 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 - Aug 22, 2024 · Class II · Z-3166-2024: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury. - Jan 2, 2024 · Class II · Z-1151-2024: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. - Jan 2, 2024 · Class II · Z-1144-2024: Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the - Jan 2, 2024 · Class II · Z-1156-2024: Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. - Oct 4, 2023 · Class II · Z-0228-2024: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance S - Feb 2, 2022 · Class II · Z-0874-2022: Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the sa - Nov 24, 2021 · Class II · Z-0724-2022: 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 - Nov 24, 2021 · Class II · Z-0725-2022: 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 - Nov 19, 2021 · Class II · Z-0416-2022: Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the - Aug 13, 2021 · Class II · Z-2475-2021: Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulate - Aug 13, 2021 · Class II · Z-2474-2021: Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulate ## Indications for use The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform: • Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. • Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). • Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: • The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room. • Allura Xper FD10 is compatible with specified magnetic navigation systems. • Combined with a qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR. Source page: https://510kreport.com/device/K141979 Methodology: https://510kreport.com/methodology