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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67781

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

Open FDA event record

Event summary

Timeline bucket
March 10, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Del Mar Reynolds Medical, Ltd.

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 Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

Z-1442-2014
Recall number
Z-1442-2014
Initiated
March 10, 2014
Classification
Class I
Status
Terminated
Quantity
16 units distributed in the US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.

Code information

SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.

Distribution pattern

USA Nationwide Distribution in the states of North Carolina and South Carolina