Recalls / —

—#214371

Product

Azurion 7 M20. Fluoroscopic X-Ray System.

FDA product code

OWB — Interventional Fluoroscopic X-Ray System

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K163715, K172822, K181830

Affected 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.

Why it was recalled

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern

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).

Timeline

Recall initiated

2025-06-04

Posted by FDA

2025-07-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.