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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion 7 M20

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 Class 2 Device Recall Azurion 7 M20see related information
Date Initiated by FirmJune 04, 2025
Date PostedJuly 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2134-2025
Recall Event ID 97055
510(K)NumberK163715 K172822 K181830 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductAzurion 7 M20. Fluoroscopic X-Ray System.
Code Information System Model No. 722079; UDI: 00884838085268; Serial No. 525, 584, 587, 613, 631, 658, 708, 774, 777, 793, 800, 801, 838, 842, 843, 862, 865, 866, 879, 881, 896, 899, 900, 905, 908, 909, 912, 915, 923, 925, 930, 939, 948, 955, 957, 992, 750, 814, 321, 370, 549, 567, 670, 687, 688, 693, 707, 743, 759, 767, 768, 775, 785, 786, 791, 819, 855, 871, 872, 902, 916, 917, 933, 936, 956, 960, 963, 965, 966, 969, 977, 993.
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
FDA Determined
Cause 2		Device Design
ActionA "Device URGENT Medical Device Correction" notification dated 6/03/2025 was mailed to consignees. Consignees are instructed to circulate the provided notification to all system users and keep a copy of the recall notification with affected devices to maintain awareness. If you notice unusual noise during C-arm roll motion, or if the C-arm roll motion is disabled and the user message Motorized movement is not available appears, immediately contact a Philips representative. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. Affected systems may continue to be used in accordance with their Instructions for Use (IFU). Complete and return the response form included in this Urgent Medical Device letter. Consignees are provided instructions to avoid rapidly pressing and releasing footswitch pedals and how to restart systems that experience the failure mode. The firm will deploy a software update in all affected system by June 2025. Consignees with any questions should contact their local Philips representative at 1-800-722-9377.
Quantity in Commerce78 units
DistributionWorldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL, IN, KY, MA, MD, MN, MO, MT, NJ, NV, NY, OH, SC, TX, WA; and OUS (Foreign) to countries of: Argentina (AR), Australia (AU), Canada (CA), Chile (CL), Germany (DE), Dominican Republic (DO), Egypt (EG), ES, France (FR), United Kingdom (GB), Italy (IT), Japan (JP), Korea, Republic (KR), Mexico (MX), Netherlands (NL), New Zealand (NZ), Oman (OM), Reunion (RE), Saudi Arabi (SA), Thailand (TH), Viet Nam (VN).
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
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