# K162859: Allura Xper FD series and Allura Xper OR Table series

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Dec 2, 2016 after 51 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 36 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K801623 (1980). 54 ancestors in all.
1 later device descends 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)
- K161563: Allura Xper FD series and Allura Xper OR Table series, Philips Medical Systems Nederland B.V. (2016) Summary page 4.

## Most influential descendants
- 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.
- 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 I · Z-1152-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class II · Z-1081-2025: 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 13, 2025 · Class I · Z-1147-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class II · Z-1086-2025: 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 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 13, 2025 · Class II · Z-1082-2025: 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 13, 2025 · Class II · Z-1076-2025: 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 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
- Jan 13, 2025 · Class II · Z-1084-2025: 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 13, 2025 · Class II · Z-1083-2025: 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 13, 2025 · Class I · Z-1148-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class II · Z-1079-2025: 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 13, 2025 · Class I · Z-1161-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1146-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- 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
- Jan 13, 2025 · Class II · Z-1085-2025: 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 13, 2025 · Class I · Z-1143-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1142-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1149-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1151-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1150-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1145-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1144-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- May 16, 2024 · Class II · Z-1896-2024: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- May 16, 2024 · Class II · Z-1895-2024: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- May 16, 2024 · Class II · Z-1897-2024: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
- 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 
- 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
- Aug 15, 2023 · Class II · Z-2587-2023: A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
- Jul 19, 2023 · Class II · Z-2402-2023: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- Jun 12, 2023 · Class II · Z-2283-2023: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

## 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/K162859
Methodology: https://510kreport.com/methodology