Class 2 Device Recall Philips Allura

• Date Initiated by Firm: June 17, 2026
• Date Posted: August 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2893-2026
• Recall Event ID: 99313
• 510(K)Number: K102005 K130638 K130842 K133292 K141979 K161563
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
• Code Information: Model Number: 722400. 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• FEI Number: 3042175844
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 6; Best Netherlands
• Manufacturer Reason for Recall: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
• FDA Determined Cause: Under Investigation by firm
• Action: Philips notified consignees on about 06/17/2026 via letter sent certified mail titled, URGENT Medical Device Correction. Consignees were instructed to circulate the notification letter to all users of the system for awareness and to follow the instructions. In the case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available. Note: Transversal stand movements (2) are only available for ceiling-mounted systems with the FlexMove option. For floor-mounted systems, only rotational (3) stand movements remain available. The table longitudinal position (4) can be adjusted manually, when the table is not tilted. Additionally, consignees were instructed to provide a copy of the notification letter to any organizations to which affected units have been transferred to, to keep the notification letter with system documentation until the correction is complete and complete and return the provided response form. Philips will inspect all affected systems and replace HDDs that are not according to the specifications, as well as correct configurations where different HDD types are used within a single system. Philips expects to start the implementation of this correction in September 2026.
• Quantity in Commerce: 257 units
• Distribution: US Nationwide 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; 510(K)s with Product Code = OWB