Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Draeger Infinity M300 and M300+ Recalled by Draeger Medical Systems, Inc. Due to The software on the Infinity CentralStation drops peaks...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Draeger Medical Systems, Inc. directly.
Affected Products
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,
Quantity: 19,429 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Draeger Medical Systems, Inc.
Draeger Medical Systems, Inc. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report