Draeger Medical Systems Infinity Central Station recall — FDA Z-1066-2025
Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
Overview of recall records associated with Draeger Medical Systems, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 6, Class I: 2.
Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include…
The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
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…
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…
The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
This page summarizes recall records in which the official source identifies Draeger Medical Systems, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.