Urodynamics tables recalled over an inadequate weld on the backrest bracket
Sonesta Medical is recalling 10 Sonesta 6210 video urodynamics procedure tables because an inadequate weld on the backrest bracket can result in the backrest dropping.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a weld failure that lets the backrest drop under a patient is a hazard, and no injuries are reported.
Plain-English summary
The Sonesta 6210, model 0120-LA120-03, a procedure table designed for full fluoroscopic imaging of the urinary tract during video urodynamics procedures, is being recalled.
The video fluoroscopy table may contain an inadequate weld on the backrest bracket, resulting in the backrest dropping.
The recall covers 10 tables carrying primary DI number 07350006950018, distributed in New Hampshire. The FDA has classified the action as Class II.
A backrest dropping while a patient is on the table is a fall and injury hazard. The enforcement record reports no injuries. Sites operating an affected table should follow the firm's instructions.
The recalled product
- 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
- Manufacturer
- Sonesta Medical AB
- Category
- Medical Device — Procedure table
- Hazard
- inadequate-weld
- component-drop
- fall-risk
Distribution
Distributed in 1 state:
- NH
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