Skip to content

Azurion 7 B20

by Philips Medical Systems Nederland B.V. Netherlands EUDAMEDGUDID

Ref 722226

Product code OWBEMDN Z11030102

Regulatory status

as of 24 Oct 2026

Recall ongoing. 64 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM328SX Basic UDI-DIDate15 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838099272 UDI-DIDate26 May 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

66 recalls · 64 ongoing · FDA

    • Ongoing Z-2932-2026 FDA Class II initiated 16 Jul 2026

    Two software related issues affecting Philips Azurion R3.0 and R3.1 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-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-1348-2026 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-1345-2026 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-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.

    • Ongoing Z-1113-2026 FDA Class II initiated 12 Dec 2025

    Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.

    • Ongoing Z-1079-2026 FDA Class II initiated 8 Dec 2025

    Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

    • Ongoing Z-0597-2026 FDA Class II initiated 27 Oct 2025

    Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

    • Ongoing Z-0719-2026 FDA Class II initiated 2 Oct 2025

    The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.

    • Ongoing Z-2502-2025 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-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).

  • 8 recalls, same reason

    • Ongoing Z-1089-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1091-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1092-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1088-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1093-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1087-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1090-2025 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

  • 8 recalls, same reason

    • Ongoing Z-1155-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1159-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1158-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1154-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1156-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1153-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1157-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1160-2025 FDA Class I initiated 13 Jan 2025

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

    • Ongoing Z-3165-2024 FDA Class II initiated 22 Aug 2024

    Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

    • Ongoing Z-2953-2024 FDA Class II initiated 6 Aug 2024

    The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.

    • Ongoing Z-2534-2024 FDA Class II initiated 15 Jul 2024

    Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

  • 3 recalls, same reason

    • Ongoing Z-1178-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1177-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1176-2024 FDA Class II initiated 6 Feb 2024

    Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

    • 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.

    • Ongoing Z-0835-2024 FDA Class II initiated 12 Dec 2023

    System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

    • Ongoing Z-0860-2024 FDA Class II initiated 8 Dec 2023

    Loss of connectivity between the FlexArm and the Table due to a software issue.

    • Ongoing Z-0861-2024 FDA Class II initiated 8 Dec 2023

    Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.

  • 8 recalls, same reason

    • 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
    • Ongoing Z-2285-2026 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.

  • 2 recalls, same reason

    • Ongoing Z-0558-2024 FDA Class II initiated 3 Nov 2023
    • Ongoing Z-0559-2024 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-0229-2024 FDA Class II initiated 4 Oct 2023

    Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

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

    Loss of availability of the wireless foot switch during procedures.

    • Ongoing Z-2284-2023 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.

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

    Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

    • Ongoing Z-0238-2022 FDA Class II initiated 24 Sep 2021

    3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.

    • Terminated Z-0737-2022 FDA Class II initiated 2 Feb 2022

    Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.

    • Completed Z-0734-2022 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.

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Azurion 7 B20 EUDAMED
Azurion GUDID
Generic Name
Stationary angiographic x-ray system, digital
Device Name
Azurion series
Model / Ref / Catalog
722226, Azurion 7 B20
Primary DI / UDI-DI
00884838099272
Basic UDI-DI
0884838BM328SX
Direct Marketing DI
00884838099272
FDA Product Code
OWB, JAA
EMDN Code
Z11030102 Stationary angiography systems for angiographic and cardiologic studies
GMDN Term
Stationary angiographic x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1650
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
722226
GUDID
Azurion 7 B20
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

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

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Serial Number
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: 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

Sources (2)

  • EUDAMED b3f690f9-d4ef-4164-9cd1-1fed422455a1 61 fields · synced 23 Oct 2026
  • FDA UDI 5a003c14-83c2-4019-937a-a306c104a9e2 34 fields · synced 30 May 2026