FDA Device recall Z-2587-2023
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
- FDA Device
- Class II
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems by Philips Medical Systems Nederland B V, citing A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2587-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-15 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | n/a |
Product
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Reason
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
Identifiers
| code_info | Models: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012,…Models: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 No UDI-DI information for foot switch component. |
|---|
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-2587-2023%22
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