Recall Z-0460-2026— Sonesta Medical AB
Class II · Ongoing
Class II FDA medical device recall by Sonesta Medical AB, initiated 2025-08-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures. Component: N/A. Reason: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping..
- Recalling firm
- Sonesta Medical AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-22
- Firm location
- Solna, Sweden
Product description
Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures. Component: N/A
Reason for recall
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Data sourced from openFDA. This site is unofficial and independent of the FDA.