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Recall Observatory FDA recall evidence

Derived label

Device software or design

ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
ICU Medical, Inc.

Field note

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