FDA recall Z-0372-2020

Draegar Medical Systems, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

US nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2019-10-09
Report date
2019-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2020