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
- Company
- Sonesta Medical Ab Industrivagen
- Recall Initiated
- August 22, 2025
- Posted
- November 7, 2025
- Recall Number
- Z-0460-2026
- Quantity
- 10 tables
Reason for Recall
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Distribution
US Distribution to NH only.
Lot / 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
Root Cause
Process control
Action Taken
On September 8, 2025, Sonesta Medical AB issued a recall notification to affected consignees via E-Mail. Sonesta asked consignees to take the following actions: 1. Please review your table and confirm that the serial number on the product labeling matches with the number listed in the notification. 2. Please discontinue use of the table. It is recommended that you place a copy of this notice on the table to provide staff awareness of the issue. 3. Sonesta will contact you to schedule and perform a table inspection as soon as possible. 4. If the table inspection results are acceptable, Sonesta will provide you with evidence to continue to use the table. 5. If the table inspection results are unacceptable, Sonesta and Laborie will work with you to replace your table If you have any questions, contact the CEO via email: Pelin.Sari@sonestamedical.se or phone +468-502 572 80.