FDA Enforcement
Class II
Ongoing
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
Recall: Z-0460-2026
·
Reported November 19, 2025
Enforcement
- Recall Number
- Z-0460-2026
- Event ID
- 97568
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Sonesta Medical AB
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- November 19, 2025
- Initiation Date
- August 22, 2025
- Classification Date
- November 7, 2025
- Address
- Industrivagen 7, Solna, N/A, Sweden
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
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Code Info
Lot Code: Primary DI Number: 07350006950018 Serial numbers of potentially affected units: 12-70791 12-70792 12-70793 12-70794 12-70795 12-70796 12-70797 12-70798 12-70799 12-70801
Distribution
US Distribution to NH only.
Quantity
10 tables