Medical Device Recall: Azurion 7 M20. Fluoroscopic X-Ray System.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · June 4, 2025
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).
States Affected
NATIONWIDE
Quantity Affected
78 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2134-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.