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Recall Observatory FDA recall evidence

Derived label

Device software or design

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

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Nihon Kohden America Inc

Field note

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