---
title: "Azurion IGTS Fixed Systems — FDA record Z-0229-2024 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-0229-2024-azurion-igts-fixed-systems/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Azurion IGTS Fixed Systems — FDA record Z-0229-2024

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 4, 2023. 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 IGTS Fixed Systems
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Philips North America
- **Quantity**: Not supplied
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0229-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0229-2024%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 | Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503 |

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

## Distribution

United States Territories of Puerto Rico, Guam, and Virgin Islands

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

## Dates in the source

- **Report date**: Nov 15, 2023
- **Recall initiation date**: Oct 4, 2023
- **Center classification date**: Nov 9, 2023

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-0229-2024%22)

## Related records

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