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Open, Classified

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

FDA Recall Z-0460-2026 · Posted 2025-11-07

Recalling FirmSonesta Medical AB
Recall StatusOpen, Classified
Product CodeIXR
Date Initiated2025-08-22
Product Quantity10 tables

Reason for Recall

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

Firm Action

On September 8, 2025, Sonesta Medical AB issued a recall notification to affected consignees via E-Mail. Sonesta asked consignees to take the following actions: 1. Please review your table and confirm that the serial number on the product labeling matches with the number listed in the notification. 2. Please discontinue use of the table. It is recommended that you place a copy of this notice on the table to provide staff awareness of the issue. 3. Sonesta will contact you to schedule and perform a table inspection as soon as possible. 4. If the table inspection results are acceptable, Sonesta will provide you with evidence to continue to use the table. 5. If the table inspection results are unacceptable, Sonesta and Laborie will work with you to replace your table If you have any questions, contact the CEO via email: [email protected] or phone +468-502 572 80.

Root Cause

Process control

Distribution Pattern

US Distribution to NH only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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