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Recall Observatory FDA recall evidence

Derived label

Device software or design

Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Draeger Medical Systems, Inc.

Field note

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