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U.S. Department of Health and Human Services

Class 2 Device Recall ALLURA XPER OR TABLE SERIES, ALLURACLARITY XPER FD SERIES XRAY SYSTEM, ALLURA XPER FD OR TABLE SERI

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 Class 2 Device Recall ALLURA XPER OR TABLE SERIES, ALLURACLARITY XPER FD SERIES XRAY SYSTEM, ALLURA XPER FD OR TABLE SERIsee related information
Date Initiated by FirmMay 18, 2026
Date PostedJune 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2412-2026
Recall Event ID 99223
510(K)NumberK102005 K130638 K130842 K133292 K141979 K161563 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductPhilips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.
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 = OWB
510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
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