The Recall Desk
HighFDA (Devices)·Z-0460-2026·Announced 2025-11-19

[pending] Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A

Pending LLM rewrite. Source: FDA_DEVICE Z-0460-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.

The recalled product

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
Manufacturer
Sonesta Medical AB

Distribution

Distributed in 1 state:

  • NH