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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68459

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nihon Kohden America 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

CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.

Z-1979-2014
Recall number
Z-1979-2014
Initiated
June 03, 2014
Classification
Class II
Status
Terminated
Recalling firm
Nihon Kohden America Inc
Quantity
430

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may

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

Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.

Code information

Model Number: CNS-6201 Software Version 02-26 only. Serial Numbers: 00485, 00488, 00489, 00490, 00491, 00361, 00429, 00430, 00432, 00436, 00443, 00447, 00478, 00486, 00546, 00564, 00573, 00574, 00575, 00576, 00592, 00626, 00638, 00643, 00651, 00674, 00675, 00677, 00678, 00679, 00687.

Distribution pattern

Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.