FDA Device recall Z-0228-2024
Allura Xper IGTS Fixed Systems
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Allura Xper 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-0228-2024 |
| 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
Allura Xper 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 | Allura Xper FD10 285 Allura Xper FD10 1517 Allura Xper FD10 1634 Allura Xper FD10 177 Allura Xper FD10 764 ALLURA Xper…Allura Xper FD10 285 Allura Xper FD10 1517 Allura Xper FD10 1634 Allura Xper FD10 177 Allura Xper FD10 764 ALLURA Xper FD10 C 249 Allura Xper FD20 2013 Allura Xper FD20 1334 Allura Xper FD20 1473 Allura Xper FD20 2110 Allura Xper FD20 2155 Allura Xper FD20 919 Allura Xper FD20 1581 Allura Xper FD20 2353 Allura Xper FD20 1811 Allura Xper FD20 2087 Allura Xper FD20 53364 Allura Xper FD20/15 172 |
|---|
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-0228-2024%22
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