Draeger Medical Systems, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1471-2023)

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 CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower

Product Classification:

Class II

Date Initiated: April 5, 2023

Date Posted: May 3, 2023

Recall Number: Z-1471-2023

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: 6803 systems

Code Information:

UDI-DI: 04049098001878; All Systems Running Software versions: ICS VG2.1.3 and lower

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated