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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Sonesta 6210 Video Fluoroscopy Tables Recalled for Backrest Drop Risk

Agency Publication Date: November 7, 2025
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Summary

Sonesta Medical AB has recalled 10 Sonesta 6210 Video Fluoroscopy Tables (Model 0120-LA120-03) because of an inadequate weld on the backrest bracket. This procedure table is designed for fluoroscopic imaging of the urinary tract during video urodynamics procedures. Due to the manufacturing defect, the backrest may drop suddenly while in use.

Risk

The inadequate weld on the backrest bracket can fail, causing the backrest to collapse or drop unexpectedly. This poses a risk of physical injury to patients or healthcare providers during medical procedures.

What You Should Do

  1. This recall involves 10 units of the Sonesta 6210 Video Fluoroscopy Table, specifically model number 0120-LA120-03.
  2. Identify if your table is affected by checking the serial number printed on the device label. The affected serial numbers are 12-70791, 12-70792, 12-70793, 12-70794, 12-70795, 12-70796, 12-70797, 12-70798, 12-70799, and 12-70801.
  3. Stop using the recalled device immediately to prevent potential patient or staff injury.
  4. Contact Sonesta Medical AB or your equipment distributor to arrange for a return, replacement, or on-site correction of the backrest bracket.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report a device-related incident.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Sonesta 6210 Video Fluoroscopy Table
Model / REF:
0120-LA120-03
Serial Numbers:
12-70791
12-70792
12-70793
12-70794
12-70795
12-70796
12-70797
12-70798
12-70799
12-70801
UDI:
07350006950018

Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97568
Status: Active
Manufacturer: Sonesta Medical AB
Sold By: Medical equipment distributors
Manufactured In: Sweden
Units Affected: 10 tables
Distributed To: New Hampshire

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.