← FDA ENFORCEMENT
Z-2411-2026Class II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product type
Device
Status
Ongoing
Report date
2026-06-24
Distribution
US and ROW.
Initiated by
FDA Mandated
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

Product description

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.

Code / lot info

All codes

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.