Infinity Central Station — Class II medical device recall Z-1066-2025
Ongoing recall by Draeger Medical Systems, Inc., reported 2025-02-05, distributed nationwide. Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can
| Recall number | Z-1066-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2025-01-14 |
| Classified | 2025-01-30 |
| Reported by FDA | 2025-02-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, EG, ES, FI, FR, GB, GR, HK, HR, ID, IE, IN, IT, JP, KE, KR, MA, MX, MY, NL, NO, NZ, PE, PH, PL, PT, RO, SA, SE, SI, SK, TH, ZA |
| Quantity | 1,013 units |
| UPC / GTIN / UDI-DI | 04048675548027, 04049098001878 |
| Serial numbers | 12946M00256, 12946M00269, 12946M00278, 12946M00314, 12946M00506, 12946M00518, 12946M00519, 12946M00532, 12946M00553, 1OQ7WR-00103, 1OQ7WR-00203, 1OQ89M-00593, 1OQ89M-00602, 1OQ89M-00610, 1OQ89M-00613, 1OQ89M-00635, 1OQ89M-00661, 1OQ89M-00663, 1OQ89M-00664, 1OQ89M-00669, 1OQ89M-00674, 1OQ89M-00675, 1OQ89M-00676, 1OQ89M-00677, 1OQ89M-00679 and 110 more |
| Model numbers | MS26800, MS34036 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1066-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.