Azurion 7 M20. Fluoroscopic X-Ray System.
This recall is currently active, issued July 18, 2025. It was issued by Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best Netherlands.
- Recall Initiated
- June 4, 2025
- Posted
- July 18, 2025
- Recall Number
- Z-2134-2025
- Quantity
- 78 units
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Distribution
Worldwide 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).
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
A "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.