[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
- Category
- Medical Device — Devices
Distribution
Distributed in 1 state:
- NH
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