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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost E

Medical DevicesSource: FDA (device) · Date: 2026-06-24

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product
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.
Reason / hazard
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
Classification
Class II
Status
Ongoing
Distribution / sold at
US and ROW.
Recall initiated
2026-05-18
Code info
All codes
Voluntary mandated
FDA Mandated
City
Best
Country
Netherlands
Event id
99223
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