Recall Z-0460-2026 ยท IXR Table, Radiographic, Tilting
Sonesta Medical AB
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
| Date | Nov 7, 2025 (initiated Aug 22, 2025) |
| Status | Open, Classified |
| Reason | Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping. |
| Root cause | Process control |
| Action | 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, Sones |
| Quantity | 10 tables |
| Distribution | US Distribution to NH only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.