FDA Device recall Z-1066-2025
Infinity Central Station
- FDA Device
- Class II
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class II recall of Infinity Central Station by Draeger Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1066-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-14 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Draeger Medical Systems |
| Distribution | US |
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.
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.
Identifiers
| code_info | Infinity CentralStation (ICS) Model Number: MS26800. UDI-DI Number: 04049098001878. Edifier Speaker Model Number: MS34…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-00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1066-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.