Draeger Medical Systems, Inc.: Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless comm

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: 19,429 systems Lot/code info: UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 and lower

UPC codes

04049098048989, 04049098095778

Source

Official record: FDA (Device enforcement) ↗

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