Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xp
FDA device recall Z-2412-2026 · posted 2026-06-16 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- 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
- Action taken
- Philips will send a customer notification dated May 18, 2026 to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and replace the hand switch with a new design hand switch.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Distribution
- US and ROW.
- Date initiated
- 2026-05-18
- Date posted
- 2026-06-16
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Allura Xper FD series and Allura Xper OR Table series (K161563) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES (K141979) | Philips Medical Systems Netherland BV | 2014-08-19 |
| ALLURA XPER FD; OR TABLE (K133292) | Philips Medical Systems Nederland B.V. | 2014-03-05 |
| ALLURACLARITY XPER FD SERIES X-RAY SYSTEM (K130638) | Philips Medical Systems Nederland B.V. | 2013-06-28 |
| ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES (K130842) | Philips Medical Systems Nederland B.V. | 2013-05-21 |
| ALLURA XPER OR TABLE SERIES (K102005) | Philips Medical Systems North America, Inc. | 2010-08-09 |