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.
- Hazard
- alarm-failure
- delayed-treatment
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.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27