Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring
FDA device recall Z-1066-2025 · posted 2025-01-30 · Open, Classified
Recall details
- Recalling firm
- Draeger Medical Systems, Inc.
- 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.
- Action taken
- Draeger 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 1,013 units
- Distribution
- 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, Belgi
- Date initiated
- 2025-01-14
- Date posted
- 2025-01-30
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Infinity CentralStation Wide (K151860) | Draeger Medical Systems, Inc. | 2015-09-02 |