Allura Xper FD Series and Allura Xper OR Table Series

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

  Firmware issue potentially leading to loss of geometry movements.

• • Ongoing Z-2893-2026 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-1075-2026 FDA Class II ·initiated 15 Dec 2025
  • Ongoing Z-1063-2026 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

  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-2629-2025 FDA Class II ·initiated 3 Sep 2025
  • 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-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
  • Ongoing Z-2632-2025 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-2189-2025 FDA Class II ·initiated 30 Jun 2025

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

• • Ongoing Z-0676-2025 FDA Class II ·initiated 11 Nov 2024

  Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.

• • Ongoing Z-2716-2024 FDA Class II ·initiated 8 Aug 2024

  A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.

• • 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-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-2485-2023 FDA Class II ·initiated 30 Jun 2023

  Loss of availability of the wireless foot switch during procedures.

• 2 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

  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.

• • Ongoing Z-0476-2022 FDA Class II ·initiated 29 Oct 2021

  Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

• • 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.

510(k) Number

K161563 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Azurion upgrade to R4

  Class IIb

  CE/MDR

• Marlin 1.5T

  Class IIb

  CE/MDR 2243595CE01 Active Valid to May 2030

• Zenition 30

  Class II

  FDA 510(k) K254205 Active Cleared 7 Aug 2026

• dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

  Class II

  FDA 510(k) K262330 Active Cleared 30 Jul 2026

• dS FootAnkle 16Ch 1.5T

  Class II

  FDA 510(k) K262294 Active Cleared 24 Jul 2026

• Multimodality Simulation Workspace (MM Sim) Upgrade

  Class IIb

  CE/MDR GUDID on market

See all devices from Philips Medical Systems Nederland B.V. →

• What procedures does the Allura Xper FD/OR Table series support?

  The Allura Xper FD and OR Table series are designed for real-time imaging during surgical and diagnostic procedures, including angiography, cardiac catheterization, and orthopedic interventions. Their high-resolution fluoroscopy enables precise visualization of anatomical structures and implanted devices, supporting minimally invasive techniques and enhancing procedural accuracy and patient safety.

• Are these systems reusable or single-use?

  These systems are reusable medical devices. They require proper cleaning, disinfection, and maintenance per manufacturer protocols to ensure sterility and functionality in sterile environments like radiology departments and operating rooms.

• What regulatory clearance does the Allura Xper series hold?

  The Allura Xper FD and OR Table series have received FDA 510K clearance for substantial equivalence, classified as Class II medical devices. This clearance confirms their compliance with U.S. regulatory standards for interventional fluoroscopic X-ray systems.

• How many model variants are available, and how do they differ?

  Multiple model variants of the Allura Xper FD and OR Table series are available, each with distinct technical specifications and imaging capabilities. These variants are tailored to accommodate various clinical workflows, ensuring compatibility with different procedural needs while maintaining high-resolution imaging for precision.

• Where are these systems intended for use?

  These systems are intended for use in radiology departments and operating rooms where sterile environments are maintained. Their design supports interventional procedures requiring real-time imaging, ensuring safe and accurate visualization during complex surgeries and diagnostics.