Z-0460-2026 Class II Ongoing

Recalled by Sonesta Medical AB — Solna

Recall Details

Product Type
Devices
Report Date
November 19, 2025
Initiation Date
August 22, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 tables

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.

Distribution Pattern

US Distribution to NH only.

Code Information

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