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Recall Observatory FDA recall evidence

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

Z-0460-2026

August 22, 2025

Class II

Product summary

Firm
Sonesta Medical AB
Event
Event 97568
Status
Ongoing
Classification
Class II
Quantity
10 tables
Official record key
device-enforcement:Z-0460-2026

Official wording

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

Code information: 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

Distribution pattern: US Distribution to NH only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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