Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description
Summary
The FDA issued a Class II for Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 So by Sonesta Medical AB. Reason: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping..
Details
Source
Device Recall
External ID
Z-0460-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 10 tables
Reason for Recall
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Distribution
US Distribution to NH only.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-22
Company
Solna
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sonesta Medical AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sonesta Medical AB have FDA actions?
This is the only FDA action we have on record for Sonesta Medical AB in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0460-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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