CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report
Brand Name: Sonesta Product Name: 6210 Model/Catalog Number recalled
Sonesta Medical AB is recalling Brand Name: Sonesta Product Name: 6210 Model/Catalog Number, distributed in New Hampshire. The recall was initiated on 22 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0460-2026
- FDA event ID
- 97568
- Recalling firm
- Sonesta Medical AB, Solna
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Aug 2025
- FDA classified
- 7 Nov 2025
- Reported
- 19 Nov 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 22 Aug 2025 | Recall initiated by company | |
| 7 Nov 2025 | Classified by FDA | +77 days |
| 19 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US Distribution to NH only.
Stores named: Walmart
Questions about this recall
Is Brand Name: Sonesta Product Name: 6210 Model/Catalog Number recalled?
Yes. Sonesta Medical AB recalled Brand Name: Sonesta Product Name: 6210 Model/Catalog Number on 22 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-0460-2026.
Why was it recalled?
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Which lots are affected?
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
Where was it sold?
US Distribution to NH only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sonesta Medical AB
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V recalled | Sonesta Medical Ab | Other | MA |
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