Recall Z-2411-2026 ยท IZI System, X-Ray, Angiographic
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.
| Date | Jun 16, 2026 (initiated May 18, 2026) |
| Status | Open, Classified |
| 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 |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Distribution | US and ROW. |
| FDA record | Open on fda.gov |