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Allura Xper or Table Series

by Philips Medical Systems North America, Inc.

510(k) K102005

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 · Traditional NumberK102005 Date9 Aug 2010ClearedStatusActive

Recalls

39 recalls · 36 ongoing · FDA

  • 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-1066-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1073-2026 FDA Class II initiated 15 Dec 2025
    • Ongoing Z-1074-2026 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-1076-2026 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-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-2624-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2627-2025 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-2630-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2632-2025 FDA Class II initiated 3 Sep 2025
    • Ongoing Z-2635-2025 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-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-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.

    • Terminated Z-1822-2017 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-0765-2016 FDA Class II initiated 3 Nov 2015

    Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).

    • Terminated Z-1120-2015 FDA Class II initiated 6 Jun 2014 on shared 510(k) K102005

    In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

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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