Class 2 Device Recall Philips Azurion Interventional Fluoroscopic XRay System

• Date Initiated by Firm: September 24, 2021
• Create Date: November 09, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0213-2022
• Recall Event ID: 88854
• 510(K)Number: K181830
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
• Code Information: Software version 2.1.x Serial Number | Unique Device Identifier (UDI#) 140 (01)00884838099258(21)140 124 (01)00884838099241(21)124 75 (01)00884838099258(21)75 824 (01)00884838085251(21)824 182 (01)00884838099258(21)182 703416 (01)00884838085268(21)703416 626 (01)00884838085251(21)626 697 (01)00884838085251(21)697 3 (01)00884838099203(21)3 703368 (01)00884838085268(21)703368 139 (01)00884838099258(21)139 159 (01)00884838099258(21)159 36 (01)00884838099241(21)36 266 (01)00884838099258(21)266 512 (01)00884838099258(21)512 703413 (01)00884838085268(21)703413 1410 (01)00884838085268(21)1410 703329 (01)00884838085268(21)703329 250 (01)00884838099258(21)250 226 (01)00884838099258(21)226 105 (01)00884838099272(21)105 360 (01)00884838099258(21)360 370 (01)00884838099258(21)370 1379 (01)00884838085268(21)1379 452 (01)00884838099258(21)452 141 (01)00884838085251(21)141 279 (01)00884838085251(21)279 644 (01)00884838085251(21)644 455 (01)00884838085268(21)455 48 (01)00884838099234(21)48 584 (01)00884838099258(21)584 239 (01)00884838099272(21)239 34 (01)00884838099258(21)34 131 (01)00884838099241(21)131 88 (01)00884838099258(21)88 890 (01)00884838085251(21)890 15 (01)00884838099210(21)15 19 (01)00884838099210(21)19 919 (01)00884838085268(21)919 33 (01)00884838099258(21)33 792 (01)00884838085268(21)792 469 (01)00884838085367(21)469 53 (01)00884838099258(21)53 469 (01)00884838085367(21)469 363 (01)00884838099258(21)363 409 (01)00884838099258(21)409 260 (01)00884838085282(21)260 261 (01)00884838085282(21)261 132 (01)00884838085275(21)132 17 (01)00884838099234(21)17 658 (01)00884838085268(21)658 425 (01)00884838099258(21)425 308 (01)00884838085367(21)308 189 (01)00884838099258(21)189 32 (01)00884838099234(21)32 131 (01)00884838085275(21)131 225 (01)00884838099258(21)225 235 (01)00884838099258(21)235 50 (01)00884838099258(21)50 209 (01)00884838085282(21)209 69 (01)00884838099241(21)69 23 (01)00884838099234(21)23 25 (01)00884838099234(21)25 107 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• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• Manufacturer Reason for Recall: When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.
• FDA Determined Cause: Software design
• Action: On September 24, 2021, the firm sent "Urgent Medical Device Correction" recall letters to affected customers (medical facilities). Customers were informed that a software defect causes the possibility for table lock-up and unavailable X-ray imaging when the APC (accept) button and the Float Tabletop (panning) button are pressed or released at the same time. If the problem occurs, there will be a delay in procedure. ACTIONS FOR THE CUSTOMER: - Do not press or release both the APC (accept) button and the Float Tabletop (panning) button at the same time during the procedure. - If the table locks up, do not perform a cold restart. It will take 6 minutes until the system is fully available again. - If the table locks up, perform a warm restart. With a warm restart the system will be fully functional after 90 seconds. Fluoroscopy will be available after 60 seconds. - Place the recall letter with the documentation of the system until Philips has installed the software update in your system. - Return the reply form attached to the recall letter. System restart options are described in section 4.2 of the Instructions for Use. The problem will be resolved by a software update. Customers will be contacted by their local Philips representative to schedule the software update for your system. If you need further information, please contact your local Philips representative: 1-800-722-9377 (reference FCO72200494)
• Quantity in Commerce: 428 (US); 581 (OUS)
• Distribution: Domestic distribution nationwide. International distribution worldwide.
• 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 = JAA and Original Applicant = Philips Medical Systems Nederland BV