# K133292: Allura Xper FD; or Table

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Mar 5, 2014 after 131 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: 10 generations back to K801623 (1980). 51 ancestors in all.
15 later devices descend from it; 2 cite it directly.
5 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130638: Alluraclarity Xper FD Series X-Ray System, Philips Medical Systems Nederland B.V. (2013) Summary page 1.
- K102005: Allura Xper or Table Series, Philips Medical Systems North America, Inc. (2010) Summary page 1.

## Most influential descendants
- K141979: Allura Xper FD Series / Allura Xper or Table Series (2014), 13 descendants of its own
- 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

## 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-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
- 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.
- 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-1078-2025: 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
- 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-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 
- Mar 14, 2018 · Class II · Z-1589-2018: After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
- Jan 4, 2018 · Class II · Z-0716-2018: There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This
- Mar 22, 2017 · Class II · Z-1820-2017: 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 1, 2016 · Class II · Z-0924-2017: 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.
- Dec 1, 2016 · Class II · Z-0925-2017: 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.

## Indications for use
The Allura Xper series and the Allurn Xper OR Table series (within (he 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. atherecromies). pacemaker inmplantations. and electrophysiology (EP). * Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: "The Altura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room. "Allura Xper FDOb is compatible with specified magnetic navigation systems. * Combined with a qualified, compatible OR table, the Altura 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/K133292
Methodology: https://510kreport.com/methodology