FDA-Device2025-11-19Class IIPROCESSING DEFECT

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

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Hazard

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

Intended for
Adults
Illnesses reported
None reported
Sold states
US Distribution to NH only.
Affected count
10 tables
Manufactured in
Industrivagen 7, Solna, Sweden
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0460-2026

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