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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity CentralStation Wide

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 Class 2 Device Recall Infinity CentralStation Widesee related information
Date Initiated by FirmJanuary 14, 2025
Date PostedJanuary 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1066-2025
Recall Event ID 96057
510(K)NumberK151860 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductInfinity 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.
Code Information 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
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
6 Tech Dr
Andover MA 01810-2434
For Additional Information ContactMike Kelhart
001-267-664-1131
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionDraeger notified consignees on about 01/14/2025 via Urgent - Medical Device Correction letter. Consignees were instructed to inspect the device to identify if the speaker is configured with the ICS in USB mode or Analog mode. For the speaker set to Analog mode there is an analog cable (aux cable) connected to the backside of the speaker and a light on frontside of the speaker display. If the light is green, there is no issue of speaker audio annunciation. If the light is red, the issue of speaker audio annunciation is present. If an issue with alarm annunciation occurs while operating, follow the steps included in the letter. Ensure all affected users or customers, if further distributed, are notified of the recall notification. They were instructed to complete and return the provided reply card.
Quantity in Commerce1,013 units
DistributionWorldwide - 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, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kenya, Malaysia, Mexico, Monaco, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Samoa, American, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkiye, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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