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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97568

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 22, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Sonesta Medical AB

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-0460-2026
Initiated
August 22, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Sonesta Medical AB
Quantity
10 tables

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.