FDA Device recall Z-0229-2024
Azurion IGTS Fixed Systems
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Azurion IGTS Fixed Systems by Philips North America, citing 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 Sour….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0229-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-04 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | PR |
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.
Identifiers
| code_info | Azurion 7 M12 465 Azurion 7 M20 702 Azurion 7 M20 942 Azurion 7 M20 948 Azurion 7 M20 503 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.