Recall Z-1472-2023— Draeger Medical Systems, Inc.

Name: FDA recall Z-1472-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-05

Class II · Ongoing

Class II FDA medical device recall by Draeger Medical Systems, Inc., initiated 2023-04-05. It names one FDA 510(k) clearance: K200859. 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,. Reason: 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..

Recalling firm: Draeger Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-05
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K200859 — Infinity M300Draeger Medical Systems, Inc.·cleared 2020-08-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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,

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.