FDA-Device2022-05-04Class II
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Draegar Medical Systems, Inc.
Hazard
Software issue resulting in temporary loss of central monitoring functionality.
Sold states
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.
Affected count
1950 (1574 OUS + 376 US)
Manufactured in
6 Tech Dr, Andover, MA, United States
Products
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2022Don't want to check this manually?
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