BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-1066-2025 · Initiated January 14, 2025

    Recall

    Recall Number
    Z-1066-2025
    Event Number
    96057
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    3005783425
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 14, 2025
    Posted
    January 30, 2025
    Address
    6 Tech Dr, Andover, MA, 01810-2434

    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

    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

    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.

    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, 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.

    Quantity

    1,013 units