# K102005: Allura Xper or Table Series

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Aug 9, 2010 after 25 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K801623 (1980). 49 ancestors in all.
24 later devices descend from it; 4 cite it directly.
5 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002016: Philips Integris Allura, Philips Medical Systems North America, Inc. (2000) Summary page 1.
- K041949: Allura Xper FD10, Philips Medical Systems North America Co. (2004) Summary page 1.
- K033737: Allura Xper FD20, Philips Medical Systems North America, Inc. (2003) Summary page 1.
- K021021: Modular Angiography System Axiom Artis, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K073290: Artis Zee and Zeego, Siemens Medical Solutions USA, Inc. (2008) Summary page 1.
- K090745: Artis Zee / Zeegos with SW VC14, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- 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

## Recalls of this device
- 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.
- 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.
- 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
- Nov 3, 2015 · Class II · Z-0765-2016: Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances
- Jun 6, 2014 · Class II · Z-1120-2015: In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

## Indications for use
The Allura Xper OR Table Series Is intended for use on human patlents (within the limits of the used OR table) to perform: * Vascular and neurovascular imaging applications, Including dlagnostic, interventional and minimally Invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal anglography, 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 Interventlons such as drainages, biopsies and vertebroplasties procedures, 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 domalns Neuro, Vascular, Non Vascular and Cardlac. The OR table can also be used standalone for surgical use In the OR.

Source page: https://510kreport.com/device/K102005
Methodology: https://510kreport.com/methodology