Azurion 7 M20. Fluoroscopic X-Ray System.
Reported: July 30, 2025 Initiated: June 4, 2025 #Z-2134-2025
Product Description
Azurion 7 M20. Fluoroscopic X-Ray System.
Reason for Recall
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Details
- Recalling Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Units Affected
- 78 units
- 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).
- Location
- Best, N/A
Frequently Asked Questions
What product was recalled? ▼
Azurion 7 M20. Fluoroscopic X-Ray System.. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 78 units.
Why was this product recalled? ▼
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2025. Severity: Moderate. Recall number: Z-2134-2025.
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