Z-0460-2026Class II

Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product...

Name: Z-0460-2026 Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product...
Creator: Sonesta Medical AB
Published: 2025-08-22
License: https://open.fda.gov/license/

Sonesta Medical AB / initiated 2025-08-22 / Open, Classified / root cause: manufacturing process

FDA source

Sonesta Medical AB began a recall of Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed... on 2025-08-22. FDA classified it as Class II and gives the reason as "Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0460-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-22
Posted: 2025-11-07
Recalling firm: 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
Product code: IXR Table, Radiographic, Tilting
Reason for recall: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 10 tables
Distribution: US Distribution to NH only.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0460-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0460-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code IXR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)