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Recall Observatory FDA recall evidence

Derived label

Device software or design

Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
cybersecurity vulnerabilities
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Draegar Medical Systems, Inc.

Field note

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