# K200917: Azurion R2.1

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: May 1, 2020 after 25 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 75 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K801623 (1980). 57 ancestors in all.
4 later devices descend from it; 2 cite it directly.
4 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172822: Azurion series R1.2, Philips Medical Systems Nederland B.V. (2017) Summary page 4.
- K181830: Azurion R2.0, Philips Medical Systems Nederland B.V. (2018) Summary page 4.

## Most influential descendants
- K251827: Azurion R3.1 (2025), 1 descendant of its own
- K243376: uAngio AVIVA CX (2025), 1 descendant of its own
- K253726: uAngio AVIVA CX (2026), 0 descendants of its own
- K254186: Azurion R3.1 (2026), 0 descendants of its own

## Recalls of this device
- Oct 6, 2026 · Not classified · Z-0295-2027: 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
- Oct 6, 2026 · Not classified · Z-0294-2027: 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
- Oct 6, 2026 · Not classified · Z-0297-2027: 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
- Oct 6, 2026 · Not classified · Z-0299-2027: 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
- Oct 6, 2026 · Not classified · Z-0293-2027: 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
- Oct 6, 2026 · Not classified · Z-0292-2027: 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
- Oct 6, 2026 · Not classified · Z-0298-2027: 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
- Oct 6, 2026 · Not classified · Z-0300-2027: 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
- Oct 6, 2026 · Not classified · Z-0296-2027: 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
- Jul 16, 2026 · Class II · Z-2932-2026: 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 tre
- Jul 16, 2026 · Class II · Z-2931-2026: 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) 
- Jun 17, 2026 · Class II · Z-2892-2026: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
- Apr 28, 2026 · Class II · Z-2225-2026: 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.
- Mar 31, 2026 · Class II · Z-2170-2026: 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 mon
- Jan 26, 2026 · Class II · Z-1346-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1345-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1347-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1344-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1350-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1349-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1348-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Jan 26, 2026 · Class II · Z-1351-2026: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Dec 12, 2025 · Class II · Z-1113-2026: 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/o
- Dec 12, 2025 · Class II · Z-1091-2026: 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
- Dec 8, 2025 · Class II · Z-1079-2026: 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
- Oct 27, 2025 · Class II · Z-0597-2026: 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 so
- Oct 2, 2025 · Class II · Z-0719-2026: 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-corro
- Aug 1, 2025 · Class II · Z-2502-2025: 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.
- May 28, 2025 · Class II · Z-1969-2025: 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 i
- Jan 13, 2025 · Class II · Z-1090-2025: 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 fin
- Jan 13, 2025 · Class I · Z-1153-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class II · Z-1087-2025: 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 fin
- Jan 13, 2025 · Class II · Z-1089-2025: 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 fin
- Jan 13, 2025 · Class I · Z-1154-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class II · Z-1093-2025: 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 fin
- Jan 13, 2025 · Class I · Z-1155-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1158-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class II · Z-1092-2025: 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 fin
- Jan 13, 2025 · Class I · Z-1160-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1159-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1157-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1156-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class II · Z-1094-2025: 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 fin
- Jan 13, 2025 · Class II · Z-1088-2025: 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 fin
- Jan 13, 2025 · Class II · Z-1091-2025: 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 fin
- Aug 22, 2024 · Class II · Z-3165-2024: 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.
- Aug 6, 2024 · Class II · Z-2953-2024: 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-corro
- Jul 15, 2024 · Class II · Z-2534-2024: Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
- Feb 6, 2024 · Class II · Z-1178-2024: 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 syste
- Feb 6, 2024 · Class II · Z-1177-2024: 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 syste

## Indications for use
The Azurion series (within the limits of the Operation Room table) are intended for use to perform • Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. • Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: • The Azurion series can be used in a hybrid Operation Room • The Azurion series contain a number of features to support a flexible and patient centric procedural workflow. Patient Population All human patients of all ages. Patient weight is limited to the specification of the patient table.

Source page: https://510kreport.com/device/K200917
Methodology: https://510kreport.com/methodology