PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for Mul…

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

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2411-2026
• FDA 510(k) clearance · K023441The device's official FDA premarket clearance record
• FDA 510(k) clearance · K050151The device's official FDA premarket clearance record
• FDA device classification · IZIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1600The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.