# K161563: Allura Xper FD series and Allura Xper OR Table series

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jul 29, 2016 after 53 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 45 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K801623 (1980). 53 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141979: Allura Xper FD Series / Allura Xper or Table Series, Philips Medical Systems Netherland BV (2014) Summary page 4.

## Most influential descendants
- K162859: Allura Xper FD series and Allura Xper OR Table series (2016), 1 descendant of its own
- K220311: Cardiovascular Angiography System (2022), 0 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-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-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
- 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
- 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-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-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-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-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-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-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-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
- 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-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-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-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-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-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
- 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-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-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-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-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-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
- 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-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-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
- Jun 30, 2025 · Class II · Z-2189-2025: Potential for temporary loss of imaging (X-ray) functionality due to software issue.
- Nov 11, 2024 · Class II · Z-0676-2025: Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed
- Aug 8, 2024 · Class II · Z-2716-2024: A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
- 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.
- 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.
- Nov 3, 2023 · Class II · Z-0558-2024: Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur re
- Jun 30, 2023 · Class II · Z-2485-2023: Loss of availability of the wireless foot switch during procedures.
- 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 
- Oct 29, 2021 · Class II · Z-0476-2022: Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

## 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/K161563
Methodology: https://510kreport.com/methodology