⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Sonesta Medical AB: Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Pro

Medical DevicesSource: FDA (device) · Date: 2025-11-19

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Sonesta Medical AB
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 / hazard
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Distribution to NH only.
Recall initiated
2025-08-22
Code info
Lot Code: Primary DI Number: 07350006950018 Serial numbers of potentially affected units: 12-70791 12-70792 12-70793 12-70794 12-70795 12-70796 12-70797 12-70798 12-70799 12-70801
Product quantity
10 tables
Voluntary mandated
Voluntary: Firm initiated
City
Solna
Country
Sweden
Event id
97568
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