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Azurion R2.0

by Philips Medical Systems Nederland B.V.

510(k) K181830

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

36 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK181830 Date2 Aug 2018ClearedStatusActive

Recalls

42 recalls · 36 ongoing · FDA

  • 9 recalls, same reason

    • Ongoing Z-0293-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0295-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0297-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0294-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0292-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0298-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0300-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0296-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0299-2027 FDA Not yet classified initiated 6 Oct 2026

    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 reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

    • Ongoing Z-2892-2026 FDA Class II initiated 17 Jun 2026

    Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

    • Ongoing Z-2225-2026 FDA Class II initiated 28 Apr 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.

    • Ongoing Z-2170-2026 FDA Class II initiated 31 Mar 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 monitor is moved or rotated.

  • 8 recalls, same reason

    • Ongoing Z-1349-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1345-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1350-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1344-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1351-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1348-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1347-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1346-2026 FDA Class II initiated 26 Jan 2026

    Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

    • Ongoing Z-1091-2026 FDA Class II initiated 12 Dec 2025

    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 mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

    • Ongoing Z-2502-2025 FDA Class II initiated 1 Aug 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.

    • Ongoing Z-2134-2025 FDA Class II initiated 4 Jun 2025

    Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

    • Ongoing Z-1969-2025 FDA Class II initiated 28 May 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 in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

    • Ongoing Z-1145-2024 FDA Class II initiated 2 Jan 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 monitor may not be possible. Issue may result in delay of procedure.

  • 8 recalls, same reason

    • Ongoing Z-2285-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2286-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2289-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2291-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2287-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2290-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2288-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2284-2026 FDA Class II initiated 7 Dec 2023

    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 pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

    • Ongoing Z-2403-2023 FDA Class II initiated 19 Jul 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

    • Ongoing Z-1647-2023 FDA Class II initiated 21 Mar 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

    • Ongoing Z-0874-2022 FDA Class II initiated 2 Feb 2022 on shared 510(k) K181830

    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 same patient or from a different patient.

    • Terminated Z-0471-2022 FDA Class II initiated 12 Nov 2021

    (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 restart is not executed correctly and movement functionality is not available

    • Terminated Z-0213-2022 FDA Class II initiated 24 Sep 2021 on shared 510(k) K181830

    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 imaging becomes unavailable.

    • Terminated Z-1809-2020 FDA Class II initiated 3 Apr 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 message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.

    • Terminated Z-1801-2020 FDA Class II initiated 5 Mar 2020 on shared 510(k) K181830

    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..

    • Terminated Z-1145-2020 FDA Class II initiated 23 Dec 2019

    Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

    • Terminated Z-1130-2019 FDA Class II initiated 12 Mar 2019 on shared 510(k) K181830

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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