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Recall Observatory FDA recall evidence

Device product

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

Z-0372-2020

October 09, 2019

Class II

Product summary

Firm
Draegar Medical Systems, Inc.
Event
Event 84028
Status
Ongoing
Classification
Class II
Quantity
12204
Official record key
device-enforcement:Z-0372-2020

Official wording

Reason: The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

Code information: All systems using Software version VG2.3.1 and lower

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    cybersecurity vulnerabilities