Azurion 7 M20 X-Ray (Philips Medical) – Gearbox Bolt Loosening (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Azurion 7 M20. Fluoroscopic X-Ray System.
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Lot Codes / Batch Numbers
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.
Products Sold
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.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands is recalling Azurion 7 M20. Fluoroscopic X-Ray System. due to Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026