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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77075

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

Open FDA event record

Event summary

Timeline bucket
March 08, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

Z-1894-2017
Recall number
Z-1894-2017
Initiated
March 08, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sonesta Medical Ab
Quantity
28 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.

Code information

12-00001-110V 12-00011-110V 23-00002-220V (Demo Product) 12-00002-110V 12-00012-110V 23-00001-220V 12-00003-110V 12-00013-110V 23-00003-220V 12-00004- 110V 12-00014-110V 23-00004-220V 12-00005-110V 12-00015-110V 23-00005-220V 12-00006-110V 12-20001-110V 23-00006-220V 12-00007-110V 12-20002-110V 23-00009-220V 12-00008-110V 12-20003-110V 23-00020-220V 12-00009-110V 12-20004 -110V 23-20001-220V 12-00010-110V 23-20002-220V

Distribution pattern

Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy