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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62589

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

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Event summary

Timeline bucket
July 09, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sentec AG

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

SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

Z-2199-2012
Recall number
Z-2199-2012
Initiated
July 09, 2012
Classification
Class II
Status
Terminated
Recalling firm
Sentec AG
Quantity
8

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

Code information

310701 311100 311239 310996 311920 311943 311958 312132

Distribution pattern

Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.