---
title: "Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTI... — FDA record Z-0597-2026 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-0597-2026-azurion-r3-0-model-number-722234-commercial-name-azurion-7-m20-interventional-fluoroscopic-xray-syst/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM — FDA record Z-0597-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Philips North America
- **Quantity**: 110
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0597-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0597-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 17, 2025
- **Recall initiation date**: Oct 27, 2025
- **Center classification date**: Dec 9, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0597-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Philips North America records](https://isitonrecall.com/brand/philips-north-america/)