# K181830: Azurion R2.0

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Aug 2, 2018 after 24 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 42 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K801623 (1980). 56 ancestors in all.
5 later devices descend from it; 1 cites it directly.
4 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172822: Azurion series R1.2, Philips Medical Systems Nederland B.V. (2017) Summary page 4.

## Most influential descendants
- K200917: Azurion R2.1 (2020), 4 descendants of its own
- K251827: Azurion R3.1 (2025), 1 descendant of its own
- K243376: uAngio AVIVA CX (2025), 1 descendant of its own
- K253726: uAngio AVIVA CX (2026), 0 descendants of its own
- K254186: Azurion R3.1 (2026), 0 descendants of its own

## Recalls of this device
- Oct 6, 2026 · Not classified · Z-0300-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Oct 6, 2026 · Not classified · Z-0297-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Oct 6, 2026 · Not classified · Z-0292-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Oct 6, 2026 · Not classified · Z-0298-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Oct 6, 2026 · Not classified · Z-0293-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Oct 6, 2026 · Not classified · Z-0294-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Oct 6, 2026 · Not classified · Z-0295-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Oct 6, 2026 · Not classified · Z-0296-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Oct 6, 2026 · Not classified · Z-0299-2027: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced
- Jun 17, 2026 · Class II · Z-2892-2026: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
- Apr 28, 2026 · Class II · Z-2225-2026: Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
- Mar 31, 2026 · Class II · Z-2170-2026: Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the mon
- Jan 26, 2026 · Class II · Z-1350-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1346-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1345-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1347-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1344-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1348-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1349-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1351-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Dec 12, 2025 · Class II · Z-1091-2026: Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart
- Aug 1, 2025 · Class II · Z-2502-2025: 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 4, 2025 · Class II · Z-2134-2025: Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
- May 28, 2025 · Class II · Z-1969-2025: A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue i
- Jan 2, 2024 · Class II · Z-1145-2024: 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 
- Dec 7, 2023 · Class II · Z-2286-2026: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch
- Dec 7, 2023 · Class II · Z-2291-2026: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch
- Dec 7, 2023 · Class II · Z-2284-2026: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch
- Dec 7, 2023 · Class II · Z-2290-2026: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch
- Dec 7, 2023 · Class II · Z-2285-2026: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch
- Dec 7, 2023 · Class II · Z-2289-2026: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch
- Dec 7, 2023 · Class II · Z-2288-2026: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch
- Dec 7, 2023 · Class II · Z-2287-2026: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch
- Jul 19, 2023 · Class II · Z-2403-2023: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- Mar 21, 2023 · Class II · Z-1647-2023: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
- 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 12, 2021 · Class II · Z-0471-2022: (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm
- Sep 24, 2021 · Class II · Z-0213-2022: When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray i
- Apr 3, 2020 · Class II · Z-1809-2020: When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning messa
- Mar 5, 2020 · Class II · Z-1801-2020: No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..
- Dec 23, 2019 · Class II · Z-1145-2020: Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
- Mar 12, 2019 · Class II · Z-1130-2019: During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.

## Indications for use
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: * Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. » Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: * The Azurion series can be used in a hybrid Operation Room. * The Azurion series contains a number of features to support a flexible and patient centric procedural workflow.

Source page: https://510kreport.com/device/K181830
Methodology: https://510kreport.com/methodology