Draeger Medical Systems, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1472-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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,

Product Classification:

Class II

Date Initiated: April 5, 2023

Date Posted: May 3, 2023

Recall Number: Z-1472-2023

Event ID: 91938

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.

Status: Ongoing

Product Quantity: 19,429 systems

Code Information:

UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 and lower

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated