Reported Feb 5, 2025 · Ongoing

Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized…

Draeger Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Draeger Medical Systems, Inc. · 6 Tech Dr · Andover, MA · 01810-2434

Is this the product you have?

  • Infinity Central Station
  • Model NumberMS26800 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
Lot codes and dates
  • Infinity
  • CentralStation (ICS) Model NumberMS26800
  • UDI-DI Number04049098001878
  • Edifier Speaker Model NumberMS34036
  • UDI-DI Number04048675548027
  • Serial Numbers

    135 of 135 codes

    • 12946M00269
    • 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
    • 1OQ8CA-00032
    • 1OQ8CA-00171
    • 1OQ8CA-00164
    • 1OQ8CA-00149
    • 1OQ8CA-00069
    • 1OQ8CA-00057
    • 1OQ8CA-00153
    • 1OQ8CA-00150
    • 1OQ8CA-00148
    • 1OQ8CA-00165
    • 1OQ8CA-00155
    • 1OQ8CA-00097
    • 1OQ8CA-00113
    • 1OQ8CA-00106
    • 1OQ8CA-00075
    • 1OQ8CA-00052
    • 1OQ8CA-00067
    • 1OQ8CA-00128
    • 1OQ8CA-00132
    • 1OQ8CA-00268
    • 1OQ8CA-00198
    • 1OQ8CA-00255
    • 1OQ8CA-00151
    • 1OQ8CA-00342
    • 1OQ8CA-00391
    • 1OQ8CA-00321
    • 1OQ8CA-00402
    • 1OQ8CA-00395
    • 1OQ8CA-00297
    • 1OQ8CA-00240
    • 1OQ89M-00691
    • 1OQ89M-00690
    • 1OQ89M-00708
    • 1OQ89M-00693
    • 1OQ89M-00687
    • 1OQ89M-00707
    • 1OQ89M-00703
    • 1OQ89M-00679
    • 1OQ89M-00683
Amount recalled
1,013 units

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.