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U.S. Department of Health and Human Services

Class 2 Device Recall Sonesta

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 Class 2 Device Recall Sonestasee related information
Date Initiated by FirmAugust 22, 2025
Date PostedNovember 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0460-2026
Recall Event ID 97568
Product Classification Table, radiographic, tilting - Product Code IXR
ProductBrand 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
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
Recalling Firm/
Manufacturer		 Sonesta Medical AB
Industrivagen 7
Solna Sweden
For Additional Information ContactPelin Sari
46812876608
Manufacturer Reason
for Recall		Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
FDA Determined
Cause 2		Process control
ActionOn September 8, 2025, Sonesta Medical AB issued a recall notification to affected consignees via E-Mail. Sonesta asked consignees to take the following actions: 1. Please review your table and confirm that the serial number on the product labeling matches with the number listed in the notification. 2. Please discontinue use of the table. It is recommended that you place a copy of this notice on the table to provide staff awareness of the issue. 3. Sonesta will contact you to schedule and perform a table inspection as soon as possible. 4. If the table inspection results are acceptable, Sonesta will provide you with evidence to continue to use the table. 5. If the table inspection results are unacceptable, Sonesta and Laborie will work with you to replace your table If you have any questions, contact the CEO via email: Pelin.Sari@sonestamedical.se or phone +468-502 572 80.
Quantity in Commerce10 tables
DistributionUS Distribution to NH only.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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