Device 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
Z-0460-2026
Product summary
- Event
- Event 97568
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 tables
- Official record key
device-enforcement:Z-0460-2026
Official wording
Reason: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
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
Distribution pattern: US Distribution to NH only.
Derived failure modes
-
Unknown
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.