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Recall Observatory FDA recall evidence

Device product

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

Z-1979-2014

June 03, 2014

Class II

Product summary

Firm
Nihon Kohden America Inc
Event
Event 68459
Status
Terminated
Classification
Class II
Quantity
430
Official record key
device-enforcement:Z-1979-2014

Official wording

Reason: 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.

Derived failure modes

  • 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