Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for
FDA device recall Z-2411-2026 · 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
- IZI
- 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 |
|---|---|---|
| MULTIDIAGNOST ELEVA (K050151) | Philips Medical Systems North America, Inc. | 2005-02-09 |
| PHILIPS MULTIDIAGNOST ELEVA (K023441) | Philips Medical Systems | 2002-10-30 |