Sonesta Medical AB: Device Recall
Recall #Z-0460-2026 · 08/22/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0460-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Sonesta Medical AB
- Status
- Ongoing
- Date Initiated
- 08/22/2025
- Location
- Solna, Sweden
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 tables
Reason for Recall
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
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
Distribution Pattern
US Distribution to NH only.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.