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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61691

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

Open FDA event record

Event summary

Timeline bucket
April 23, 2012
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Sigma

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

SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.

Z-2030-2012
Recall number
Z-2030-2012
Initiated
April 23, 2012
Classification
Class III
Status
Terminated
Recalling firm
Sigma
Quantity
2,048 CD's

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software associated with the SIGMA Spectrum Infusion Pump System because it may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.

Code information

All versions

Distribution pattern

Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.