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Draeger Medical Systems, Inc. recalls Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the h
Recalled May 3, 2023 · FDA recall Z-1471-2023 · Draeger Medical Systems
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. · FDA Class II
Units
6803 systems
Sold at
Worldwide - US Nationwide distribution.
Description
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.
Product
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
Manufacturer(s)
Draeger Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →