FDAApril 5, 2023device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
draeger medical systemsdraegerdraeger medical
UPCs
04049098001878
Recall history
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