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Open, Classified

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.

FDA Recall Z-2411-2026 · Posted 2026-06-16

Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall StatusOpen, Classified
Product CodeIZI
Date Initiated2026-05-18

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

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US and ROW.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050151MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc. · 2005-02-09K023441PHILIPS MULTIDIAGNOST ELEVAPhilips Medical Systems · 2002-10-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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