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Recall Observatory FDA recall evidence

Device 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.

Z-1066-2025

January 14, 2025

Class II

Product summary

Firm
Draeger Medical Systems, Inc.
Event
Event 96057
Status
Ongoing
Classification
Class II
Quantity
1,013 units
Official record key
device-enforcement:Z-1066-2025

Official wording

Reason: 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.

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

Distribution pattern: Worldwide - 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.