PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. Fluoroscopic X-Ray System.
- Recall date
- June 4, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2134-2025
- FDA classification
- Class II
- Brand / firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Sold / distributed
- 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), Unite…
Why it was recalled
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Azurion 7 M20. Fluoroscopic X-Ray System.
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