Draeger Medical Systems, Inc.: Device Recall
Recall #Z-1066-2025 · 01/14/2025
Recall Details
- Recall Number
- Z-1066-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Draeger Medical Systems, Inc.
- Status
- Ongoing
- Date Initiated
- 01/14/2025
- Location
- Andover, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,013 units
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.
Product 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.
Distribution Pattern
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.
Other Recalls by Draeger Medical Systems, Inc.
- Class II: Risk 05/13/2024