FDA-Device2025-07-30Class II
Azurion 7 M20. Fluoroscopic X-Ray System.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Sold states
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).
Affected count
78 units
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Azurion 7 M20. Fluoroscopic X-Ray System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2134-2025Don't want to check this manually?
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