High FDA (Devices)·Z-1066-2025·Announced 2025-02-05

Infinity Central Station speakers may fail to produce critical patient alarms

Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.

What this means for you

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: This is a Class II FDA medical device where audible alarms may fail to notify clinicians of critical patient monitoring events. Although no injuries or hospitalizations have been reported, the risk of delayed patient treatment is significant in a hospital-critical device, meeting the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Infinity Central Station (ICS), Model MS26800, is a centralized patient monitoring system used in hospitals and clinical environments to display and manage data from networked patient monitors, including visual and audible alerts for patients of all ages (adult, pediatric, and neonatal).

Approximately 1,013 units of the Infinity Central Station contain Edifier speakers that may fail to produce audible alarms (annunciate) when configured in analog mode. This failure could prevent healthcare staff from receiving critical audible alerts about patient monitoring events, potentially delaying treatment.

The affected devices were distributed worldwide, including throughout the United States and multiple countries in North America, South America, Europe, Africa, Asia, Australia, and the Pacific region. Specific serial numbers and UDI identification numbers are documented in the recall notice.

Healthcare facilities should contact Draeger Medical Systems, Inc. to determine if they have affected units and obtain instructions for remediation of this issue.

The recalled product

Product: 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 dat
Manufacturer: Draeger Medical Systems, Inc.
Category: Medical Device — Patient Monitoring System
Hazard: alarm-failure
delayed-treatment
Affected units: 1,013

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 (20)

12946M00314
12946M00506
12946M00519
12946M00518
12946M00553
1OQ7WR-00103
1OQ8CA-00249
1OQ8CA-00254
1OQ8CA-00229
1OQ8CA-00221
1OQ8CA-00282
1OQ8CA-00314
1OQ8CA-00193
1OQ8CA-00200
1OQ8CA-00194
1OQ8CA-00181
1OQ8CA-00178
1OQ8CA-00248
1OQ8CA-00125
1OQ8CA-00071

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Same manufacturer · Draeger Medical Systems, Inc.

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Same hazard · alarm failure