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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70793

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

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Event summary

Timeline bucket
March 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smiths Medical ASD, Inc.

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

Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.

Z-1692-2015
Recall number
Z-1692-2015
Initiated
March 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
5 UPDATE 4-20-2015 to include 10 additional devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.

Code information

Serial Numbers: 4059587 through 4059591 UPDATED 4-20-2015: additional devices affected have serial numbers: 4059949, 4059950, 4059951, 4059952, 4059953, 4059954, 4059955, 4059957, 4059958 and 4059960

Distribution pattern

MN