Exact FDA event identifier

Event 68611

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

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Event summary

Timeline bucket: June 18, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Spacelabs Healthcare 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

Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.

Z-2077-2014

Recall number: Z-2077-2014
Initiated: June 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Spacelabs Healthcare Inc
Quantity: 8 units total (3 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

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

With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

Code information

Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209

Distribution pattern

Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.