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Recall Observatory FDA recall evidence

Derived label

Device software or design

V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
failure because after recalibration, the sensors stayed in the software
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
SenTec AG

Field note

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