Sonesta Medical AB recalls Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software…

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

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: Pelin.Sari@sonestamedical.se or phone +468-502 572 80.

• FDA enforcement recordOfficial FDA database entry for Z-0460-2026
• FDA device classification · IXROfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1980The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Sonesta Medical ABSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.