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Allura Xper Fd Series / Allura Xper or Table Series

by Philips Medical Systems Netherland BV

510(k) K141979

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

47 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 NumberK141979 Date19 Aug 2014ClearedStatusActive

Recalls

81 recalls · 47 ongoing · FDA

    • Ongoing Z-2928-2026 FDA Class II initiated 29 Jun 2026

    Firmware issue potentially leading to loss of geometry movements.

  • 2 recalls, same reason

    • Ongoing Z-2893-2026 FDA Class II initiated 17 Jun 2026
    • Ongoing Z-2891-2026 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-2412-2026 FDA Class II initiated 18 May 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 injection

  • 2 recalls, same reason

    • Ongoing Z-2259-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2258-2026 FDA Class II initiated 30 Apr 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 the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

  • 16 recalls, same reason

    • Ongoing Z-1073-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1064-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1069-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1077-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1070-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1067-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1072-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1074-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1065-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1068-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1071-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1062-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1066-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1076-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1063-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1075-2026 FDA Class II initiated 15 Dec 2025

    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 adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

  • 13 recalls, same reason

    • Ongoing Z-2630-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2632-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2625-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2631-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2633-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2634-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2629-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2624-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2635-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2627-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2623-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2628-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2626-2025 FDA Class II initiated 3 Sep 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 movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

    • Ongoing Z-2503-2025 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-2504-2025 FDA Class II initiated 1 Aug 2025

    Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

    • Ongoing Z-2189-2025 FDA Class II initiated 30 Jun 2025

    Potential for temporary loss of imaging (X-ray) functionality due to software issue.

    • Ongoing Z-1080-2025 FDA Class II initiated 13 Jan 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 finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

    • Ongoing Z-3166-2024 FDA Class II initiated 22 Aug 2024

    Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

    • Ongoing Z-1151-2024 FDA Class II initiated 2 Jan 2024

    Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

    • Ongoing Z-1156-2024 FDA Class II initiated 2 Jan 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.

    • Ongoing Z-1144-2024 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.

    • Ongoing Z-0228-2024 FDA Class II initiated 4 Oct 2023

    Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

    • Ongoing Z-0874-2022 FDA Class II initiated 2 Feb 2022 on shared 510(k) K141979

    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.

  • 3 recalls, same reason

    • Ongoing Z-0725-2022 FDA Class II initiated 24 Nov 2021
    • Ongoing Z-0724-2022 FDA Class II initiated 24 Nov 2021
    • Terminated Z-1820-2017 FDA Class II initiated 22 Mar 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 the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

    • Terminated Z-0416-2022 FDA Class II initiated 19 Nov 2021

    Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.

  • 2 recalls, same reason

    • Terminated Z-2475-2021 FDA Class II initiated 13 Aug 2021
    • Terminated Z-2474-2021 FDA Class II initiated 13 Aug 2021

    Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.

  • 3 recalls, same reason

    • Terminated Z-1494-2020 FDA Class II initiated 30 Dec 2019
    • Terminated Z-1486-2020 FDA Class II initiated 30 Dec 2019
    • Terminated Z-1493-2020 FDA Class II initiated 30 Dec 2019

    A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

  • 6 recalls, same reason

    • Terminated Z-3232-2018 FDA Class II initiated 16 Jul 2018
    • Terminated Z-3236-2018 FDA Class II initiated 16 Jul 2018
    • Terminated Z-3235-2018 FDA Class II initiated 16 Jul 2018
    • Terminated Z-3234-2018 FDA Class II initiated 16 Jul 2018
    • Terminated Z-3233-2018 FDA Class II initiated 16 Jul 2018
    • Terminated Z-3231-2018 FDA Class II initiated 16 Jul 2018

    There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.

    • Terminated Z-0716-2018 FDA Class II initiated 4 Jan 2018

    There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may also generate a peculiar burning smell that may be noticed. In some instances this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality is reduced.

    • Terminated Z-0717-2018 FDA Class II initiated 20 Dec 2017

    Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.

  • 2 recalls, same reason

    • Terminated Z-2670-2016 FDA Class II initiated 7 Jul 2016
    • Terminated Z-2669-2016 FDA Class II initiated 7 Jul 2016

    Increase in the failure rate of certain low-voltage DC power supplies (DCPS)

    • Terminated Z-1904-2021 FDA Class II initiated 23 Jun 2016

    Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.

  • 15 recalls, same reason

    • Terminated Z-0706-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0714-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0710-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0704-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0709-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0702-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0703-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0711-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0715-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0708-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0707-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0713-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0705-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0716-2016 FDA Class II initiated 3 Nov 2015
    • Terminated Z-0712-2016 FDA Class II initiated 3 Nov 2015

    The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

    • Terminated Z-1066-2016 FDA Class II initiated 1 Oct 2015

    Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.

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