Z-1066-2025 Class II Ongoing
Recalled by Draeger Medical Systems, Inc.
— Andover, MA
FDA device recall Z-1066-2025 was initiated by Draeger Medical Systems, Inc. on January 14, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1,013 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- January 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,013 units
Product Description
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.
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.
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.
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