FDA recall Z-0460-2026

Sonesta Medical AB · Class II · device

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

Reason for recall

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

Distribution

US Distribution to NH only.

Key facts

Status
Ongoing
Initiation date
2025-08-22
Report date
2025-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Solna, Sweden

Primary source

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