Class II U.S. Food and Drug Administration

Brand Name: Sonesta Product Name: 6210 Model/ recall: Video fluoroscopy table may contain inadequate weld on backrest bracket

Recall published 11 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0460-2026
Published
November 19, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Sonesta Medical AB
Product type
Medical devices
Units affected
10 tables
Distribution
New Hampshire
Made in
Sweden
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
UPC codes
07350006950018

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07350006950018

Model or item number

On the rating label, the box or the instruction sheet.

  • 0120-LA120-03 Software Version

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Sonesta Medical AB — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Sonesta Medical AB — Industrivagen 7, Solna

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Sonesta Medical AB medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07350006950018; model number 0120-LA120-03 Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists New Hampshire.

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