Home / Recalls / Medical Devices
Draeger Medical Systems, Inc. recalls Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory
Recalled May 3, 2023 · FDA recall Z-1472-2023 · 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
19,429 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 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 communication over the Infinity patient monitoring network,
Manufacturer(s)
Draeger Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →