Medical device recalls Moderate risk

Draegar Medical Systems, Inc. recalls Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wi…

Recall date
March 4, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1012-2022
FDA classification
Class II
Brand / firm
Draegar Medical Systems, Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.

Why it was recalled

Software issue resulting in temporary loss of central monitoring functionality.

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

What was recalled

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

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