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Allura Xper FD series and Allura Xper OR Table series

by Philips Medical Systems Nederland B.V. 2 variants

510(k) K162859

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 NumberK162859 Date2 Dec 2016ClearedStatusActive

Recalls

36 recalls · 36 ongoing · FDA

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

    Firmware issue potentially leading to loss of geometry movements.

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

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

  • 11 recalls, same reason

    • Ongoing Z-1080-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1084-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1082-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1079-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1086-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1083-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1081-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1077-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1085-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1078-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1076-2025 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

  • 12 recalls, same reason

    • Ongoing Z-1146-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1152-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1147-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1148-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1143-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1161-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1151-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1144-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1149-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1142-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1150-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1145-2025 FDA Class I initiated 13 Jan 2025

    Possibility of the patient falling from the table related to the mattress used on the patient table.

  • 3 recalls, same reason

    • Ongoing Z-1895-2024 FDA Class II initiated 16 May 2024
    • Ongoing Z-1896-2024 FDA Class II initiated 16 May 2024
    • Ongoing Z-1897-2024 FDA Class II initiated 16 May 2024

    When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

    • 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-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-0558-2024 FDA Class II initiated 3 Nov 2023

    Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

    • Ongoing Z-2587-2023 FDA Class II initiated 15 Aug 2023

    A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

    • Ongoing Z-2402-2023 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-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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