FDA Device recall Z-2412-2026
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C
- FDA Device
- Class II
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class II recall of Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C by Philips Medical Systems Nederland B V, citing philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2412-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-18 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | n/a |
Product
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.
Reason
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Identifiers
| code_info | All codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Philips Medical Systems Nederland B V
- Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and…
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 72222…
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10
FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V - Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12
FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V
All Philips Medical Systems Nederland B V recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2412-2026%22
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