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U.S. Department of Health and Human Services

Class 2 Device Recall PHILIPS MULTIDIAGNOST ELEVA, MULTIDIAGNOST ELEVA

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 Class 2 Device Recall PHILIPS MULTIDIAGNOST ELEVA, MULTIDIAGNOST ELEVAsee related information
Date Initiated by FirmMay 18, 2026
Date PostedJune 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2411-2026
Recall Event ID 99223
510(K)NumberK023441 K050151 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductPhilips 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 Information All codes
FEI Number 3002807880
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer 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
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips 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.
DistributionUS and ROW.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IZI
510(K)s with Product Code = IZI
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