Brand Name: Sonesta recallZ-0460-2026 · Sonesta Medical AB · initiated Aug 22, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sonesta Medical AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0460-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 22, 2025
- Posted by the FDA
- Nov 7, 2025
- Recalling firm
- Sonesta Medical AB
- Quantity
- 10 tables
- Product code
- IXR
- Distribution
- US Distribution to NH only.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sonesta 6210Sonesta Medical AB · Table, Radiographic, Tilting1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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