Class II — Sonesta Medical AB
| Recalling firm | Sonesta Medical AB |
|---|---|
| Registered facility | SONESTA MEDICAL AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping. |
| Product | 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 |
| Quantity | 10 tables |
| Distribution | US Distribution to NH only. |
| Initiated | 2025-08-22 |
| Classified | 2025-11-07 |
| Recall number | Z-0460-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sonesta Medical AB (Z-0460-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97568/
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