# K172822: Azurion series R1.2 - Pathway: 510(k) (Special) - Applicant: Philips Medical Systems Nederland B.V. - Decided: Nov 22, 2017 after 65 days - Product code: OWB (Interventional Fluoroscopic X-Ray System) - Device class: 2 - Regulation: 21 CFR 892.1650 - Recalls of this device: 53 (9 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 14 generations back to K801623 (1980). 55 ancestors in all. 6 later devices descend from it; 2 cite 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) - K163715: Allura Xper R9, Philips Medical Systems Nederland B.V. (2017) Summary page 4. ## Most influential descendants - K181830: Azurion R2.0 (2018), 5 descendants of its own - 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 ## Recalls of this device - 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-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 - 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-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-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-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-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 - Jul 16, 2026 · Class II · Z-2931-2026: Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) - 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-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-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-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-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-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 13, 2025 · Class I · Z-1160-2025: Possibility of the patient falling from the table related to the mattress used on the patient table. - Jan 13, 2025 · Class II · Z-1093-2025: 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-1159-2025: Possibility of the patient falling from the table related to the mattress used on the patient table. - Jan 13, 2025 · Class II · Z-1092-2025: 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-1094-2025: 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-1154-2025: Possibility of the patient falling from the table related to the mattress used on the patient table. - Jan 13, 2025 · Class I · Z-1157-2025: 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-1153-2025: Possibility of the patient falling from the table related to the mattress used on the patient table. - Jan 13, 2025 · Class I · Z-1156-2025: Possibility of the patient falling from the table related to the mattress used on the patient table. - Jan 13, 2025 · Class I · Z-1158-2025: 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. - 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 - Jan 2, 2024 · Class II · Z-1152-2024: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. - 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 - 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 - May 26, 2021 · Class II · Z-0886-2022: In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the stud ## 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 contain a number of features to support a flexible and patient centric procedural workflow. Patient Population All human patients of all ages. Patient weight is limited to the specification of the patient table. Source page: https://510kreport.com/device/K172822 Methodology: https://510kreport.com/methodology