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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
Recalled May 4, 2022 · FDA recall Z-1012-2022 · Draegar Medical Systems
Hazard
Software issue resulting in temporary loss of central monitoring functionality. · FDA Class II
Units
1950 (1574 OUS + 376 US)
Sold at
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.
Description
Software issue resulting in temporary loss of central monitoring functionality.
Product
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Manufacturer(s)
Draegar Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →