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Recall Observatory FDA recall evidence

Derived label

Device software or design

Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
malfunction of software
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Ascom US, INC.

Field note

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