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Alluraclarity Xper Fd Series X-Ray System

by Philips Medical Systems Nederland B.V.

510(k) K130638

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

39 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 NumberK130638 Date28 Jun 2013ClearedStatusActive

Recalls

39 recalls · 39 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-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
    • Ongoing Z-2630-2025 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-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-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-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-2283-2023 FDA Class II initiated 12 Jun 2023

    The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

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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