medical MODERATE Updated 2025-02-05

Draeger Medical Systems, Inc. recalls Infinity Central Station. Model Number: MS26800 The Infin

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Recalled 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 data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Infinity CentralStation (ICS) Model Number: MS26800. UDI-DI Number: 04049098001878. Edifier Speaker Model Number: MS34036. UDI-DI Number: 04048675548027. Serial Numbers: 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, 1OQ89M-00692, 1OQ89M-00610, 1OQ89M-00613, 1OQ89M-00669, 1OQ89M-00635, 1OQ89M-00664, 1OQ89M-00697, P1OQ84F-00080, 1OQ89M-00684, 1OQ89M-00676, 1OQ89M-00695, 1OQ8CA-00086, 1OQ89M-00677, 1OQ8CA-00031, 1OQ8CA-00027, 1OQ8CA-00065, 1OQ8CA-00092, 1OQ8CA-00082, 1OQ89M-00602, 1OQ89M-00680, 1OQ89M-00675, 1OQ89M-00593, 1OQ89M-00686, 1OQ89M-00696, 1OQ89M-00681, 1OQ89M-00704, 1OQ89M-00674, 1OQ89M-00661, 1OQ89M-00663, P1OQ89M-00559, P1OQ89M-00540, 1OQ8CA-00134, 1OQ8CA-00095, 1OQ8CA-00043, 1OQ8CA-00074, 1OQ8CA-00762, 1OQ8CA-00688, 1OQ8CA-00670, 1OQ8CA-00637, 1OQ8CA-00633, 1OQ8E8-00037, 1OQ8E8-00053, 1OQ8CA-00773, 1OQ8CA-00683, 1OQ8CA-00500, 1OQ8CA-00476, 1OQ8CA-00449, 1OQ8CA-00420, 1OQ8CA-00460, 1OQ8CA-00463, 1OQ8CA-00507, 1OQ8CA-00350, 1OQ8CA-00442, 1OQ8CA-00433, 1OQ8CA-00447, 1OQ8CA-00601, 1OQ8CA-00604, 1OQ8CA-00695, 1OQ8CA-00513, 1OQ8CA-00575, 1OQ8CA-00577, 1OQ8CA-00591, 1OQ8CA-00197, 1OQ8CA-00516, 1OQ8CA-00541, 1OQ8CA-00542, 1OQ8CA-00568, 1OQ8CA-00499, 1OQ8CA-00498, P12051M00227, 1OQ8CA-00593, 12946M00532, 12946M00256, 12946M00278, 1OQ7WR-00203

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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