The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1472-2023·Announced 2023-05-03

Draeger Infinity M300 Patient Monitor Software Displays Inaccurate ECG Readings

Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The software defect causes ECG waveforms to display with inaccurate amplitudes, which represents a risk of harm in a critical patient monitoring device where injury has not yet been reported.

Plain-English summary

Draeger Medical Systems is recalling approximately 19,429 Draeger Infinity M300 and M300+ patient monitoring systems that were distributed worldwide with US nationwide availability. These systems are used with the Infinity ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients.

The software on the Infinity CentralStation (running software versions VG2.4 and lower) has a defect where it drops peaks on narrow waveforms. This causes the affected systems to fail to meet Frequency and Impulse Response requirements.

As a result, ECG waveforms with narrow and/or high frequency QRS complexes may be displayed or printed with QRS amplitudes that are intermittently lower than the actual patient values. This measurement inaccuracy could potentially affect clinical assessment and patient care decisions based on the ECG data.

The recalled product

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
Draeger Medical Systems, Inc.
Category
Medical Device — Patient Monitoring / Cardiac
Hazard
Affected units
19,429

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Draeger Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Draeger Medical Systems, Inc.

See all →

Similar recalls