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Allura Xper FD Allura Xper R9 7 M20

by Philips Medical Systems Nederland B.V.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

53 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884838083448 UDI-DI Date31 Mar 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

56 recalls · 53 ongoing · FDA

  • 9 recalls, same reason

    • Ongoing Z-0294-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0299-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0293-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0295-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0297-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0292-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0298-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0300-2027 FDA Not yet classified initiated 6 Oct 2026
    • Ongoing Z-0296-2027 FDA Not yet classified initiated 6 Oct 2026

    Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

    • Ongoing Z-2931-2026 FDA Class II initiated 16 Jul 2026

    Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

    • Ongoing Z-2892-2026 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-2225-2026 FDA Class II initiated 28 Apr 2026

    Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

    • Ongoing Z-2170-2026 FDA Class II initiated 31 Mar 2026

    Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.

  • 8 recalls, same reason

    • Ongoing Z-1345-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1349-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1346-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1350-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1344-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1351-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1348-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1347-2026 FDA Class II initiated 26 Jan 2026

    Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

    • Ongoing Z-1091-2026 FDA Class II initiated 12 Dec 2025

    Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

  • 2 recalls, same reason

    • Ongoing Z-2502-2025 FDA Class II initiated 1 Aug 2025
    • 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-2134-2025 FDA Class II initiated 4 Jun 2025

    Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

    • Ongoing Z-1969-2025 FDA Class II initiated 28 May 2025

    A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

  • 3 recalls, same reason

    • Ongoing Z-1092-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1093-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1094-2025 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

  • 9 recalls, same reason

    • Ongoing Z-1144-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1160-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1157-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1153-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1156-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1142-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1154-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1158-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1159-2025 FDA Class I initiated 13 Jan 2025

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

  • 2 recalls, same reason

    • Ongoing Z-1151-2024 FDA Class II initiated 2 Jan 2024
    • Ongoing Z-1152-2024 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-1145-2024 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.

  • 8 recalls, same reason

    • Ongoing Z-2285-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2286-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2289-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2291-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2287-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2290-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2288-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2284-2026 FDA Class II initiated 7 Dec 2023

    During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

    • 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-2403-2023 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-0874-2022 FDA Class II initiated 2 Feb 2022 on shared 510(k) K172822

    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.

    • Ongoing Z-0886-2022 FDA Class II initiated 26 May 2021

    In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

    • Terminated Z-1145-2020 FDA Class II initiated 23 Dec 2019

    Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

    • Terminated Z-2205-2019 FDA Class II initiated 16 Jul 2019

    The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.

    • Terminated Z-1997-2019 FDA Class II initiated 30 Nov 2018

    Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.

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 — GUDID listing Listed

Specification

GUDID

Trade Name
Allura Xper FD
Generic Name
Stationary angiographic x-ray system, digital
Model / Ref / Catalog
Allura Xper R9 7 M20, 722066
Primary DI / UDI-DI
00884838083448
FDA Product Code
JAA, OWB
GMDN Term
Stationary angiographic x-ray system, digital
Device Class
Class II
Regulation Number
892.1650
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K163715)

Cleared under the same submission (K172822)

Other devices from Philips Medical Systems Nederland B.V.

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

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No