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RecallWatchMedical Device Safety
Class IIOngoingZ-1066-2025

Draeger Medical Systems, Inc. recalls Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is…

Draeger Medical Systems, Inc.Andover, MA, United StatesReported Feb 5, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI NumberModel Number
    135 affected lots
    12946M0026912946M0031412946M0050612946M0051912946M0051812946M005531OQ7WR-001031OQ8CA-00249
    +127 more1OQ8CA-002541OQ8CA-002291OQ8CA-002211OQ8CA-002821OQ8CA-003141OQ8CA-001931OQ8CA-002001OQ8CA-001941OQ8CA-001811OQ8CA-001781OQ8CA-002481OQ8CA-001251OQ8CA-000711OQ8CA-000321OQ8CA-001711OQ8CA-001641OQ8CA-001491OQ8CA-000691OQ8CA-000571OQ8CA-001531OQ8CA-001501OQ8CA-001481OQ8CA-001651OQ8CA-001551OQ8CA-000971OQ8CA-001131OQ8CA-001061OQ8CA-000751OQ8CA-000521OQ8CA-000671OQ8CA-001281OQ8CA-001321OQ8CA-002681OQ8CA-001981OQ8CA-002551OQ8CA-001511OQ8CA-003421OQ8CA-003911OQ8CA-003211OQ8CA-004021OQ8CA-003951OQ8CA-002971OQ8CA-002401OQ89M-006911OQ89M-006901OQ89M-007081OQ89M-006931OQ89M-006871OQ89M-007071OQ89M-007031OQ89M-006791OQ89M-006831OQ89M-006921OQ89M-006101OQ89M-006131OQ89M-006691OQ89M-006351OQ89M-006641OQ89M-00697P1OQ84F-000801OQ89M-006841OQ89M-006761OQ89M-006951OQ8CA-000861OQ89M-006771OQ8CA-000311OQ8CA-000271OQ8CA-000651OQ8CA-000921OQ8CA-000821OQ89M-006021OQ89M-006801OQ89M-006751OQ89M-005931OQ89M-006861OQ89M-006961OQ89M-006811OQ89M-007041OQ89M-006741OQ89M-006611OQ89M-00663P1OQ89M-00559P1OQ89M-005401OQ8CA-001341OQ8CA-000951OQ8CA-000431OQ8CA-000741OQ8CA-007621OQ8CA-006881OQ8CA-006701OQ8CA-006371OQ8CA-006331OQ8E8-000371OQ8E8-000531OQ8CA-007731OQ8CA-006831OQ8CA-005001OQ8CA-004761OQ8CA-004491OQ8CA-004201OQ8CA-004601OQ8CA-004631OQ8CA-005071OQ8CA-003501OQ8CA-004421OQ8CA-004331OQ8CA-004471OQ8CA-006011OQ8CA-006041OQ8CA-006951OQ8CA-005131OQ8CA-005751OQ8CA-005771OQ8CA-005911OQ8CA-001971OQ8CA-005161OQ8CA-005411OQ8CA-005421OQ8CA-005681OQ8CA-004991OQ8CA-00498P12051M002271OQ8CA-0059312946M0053212946M0025612946M002781OQ7WR-00203

What the firm is doing

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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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