Z-0460-2026 Class II Ongoing
FDA device recall Z-0460-2026 was initiated by Sonesta Medical AB on Aug 22, 2025 and is designated Class II. Reason for recall: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping. The recall status is ongoing. Affected quantity: 10 tables.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 19, 2025
- Initiation Date
- Aug 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 tables
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
Reason for Recall
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Distribution Pattern
US Distribution to NH only.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0460-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026