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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. Fluoroscopic X-Ray System.
Recalled July 30, 2025 · FDA recall Z-2134-2025 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Hazard
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. · FDA Class II
Units
78 units
Sold at
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).
Description
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Product
Azurion 7 M20. Fluoroscopic X-Ray System.
Manufacturer(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →