FDA Medical devices recall ·
Sonesta Product Name: 6210 Model recall
- Recall number
- Z-0460-2026
- Date
- (initiated August 22, 2025)
- Company / brand
- Sonesta Medical AB
Industrivagen 7, Solna, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10 tables
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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
Distribution
US Distribution to NH only.
States: New Hampshire
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0460-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.