Recall archive / FDA device enforcement
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems — FDA record Z-2587-2023
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 Aug 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 19,115 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2587-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 20, 2023
- Recall initiation date
- Aug 15, 2023
- Center classification date
- Sep 14, 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.