Recall Z-1066-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical Systems, Inc.
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 centr
| Date | Jan 30, 2025 (initiated Jan 14, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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, follo |
| Quantity | 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, Belgium, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Finlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151860 | Infinity CentralStation Wide Draeger Medical Systems, Inc., Sep 2, 2015 |