Draeger Medical Systems, Inc. recalls Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitorin…

Recall date

January 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1066-2025

FDA classification

Class II

Brand / firm

Draeger Medical Systems, Inc.

Sold / distributed

Worldwide - US Nationwide distribution in the states of AL, AS, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, NE, NY, OK, PA, SD, TN, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Finla…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.