Medical device recalls Moderate risk

Draegar Medical Systems, Inc. recalls Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031,…

Recall date
October 9, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0372-2020
FDA classification
Class II
Brand / firm
Draegar Medical Systems, Inc.
Sold / distributed
US nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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