FDA-Device2023-05-03Class II
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Draeger Medical Systems, Inc.
Hazard
The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
Sold states
Worldwide - US Nationwide distribution.
Affected count
6803 systems
Manufactured in
6 Tech Dr, N/A, Andover, MA, United States
Products
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1471-2023Don't want to check this manually?
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