Class 2 Device Recall Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnostEleva syste

• Date Initiated by Firm: August 15, 2023
• Date Posted: September 14, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2587-2023
• Recall Event ID: 92901
• 510(K)Number: K050151 K162859 K163715 K200917
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
• Code Information: Models: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 No UDI-DI information for foot switch component.
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 4-6; Best Netherlands
• Manufacturer Reason for Recall: A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
• FDA Determined Cause: Device Design
• Action: US customers were notified via certified mail via USPS. OUS customers were notified through the Philips Markets Organizations. Philips is issuing two Urgent Medical Device Correction letters, one for Allura and Azurion customers and another one for MultiDiagnost Eleva Customers. Additionally, an IFU addendum will be provided to customers that includes instructions on how to handle the footswitch cable. For Allura and Azurion customers an updated preventative maintenance manual update is also being provided. Philips will contact customers to schedule a visit to inspect the foot switch and to provide an IFU Addendum.
• Quantity in Commerce: 19,115 systems
• Distribution: Worldwide distribution
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = OWB; 510(K)s with Product Code = OWB