Draeger Medical Systems, Inc.: Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software version

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution. Quantity: 6803 systems Lot/code info: UDI-DI: 04049098001878; All Systems Running Software versions: ICS VG2.1.3 and lower

UPC codes

04049098001878

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.