Draeger Medical Systems, Inc. is recalling 1,013 Infinity Central Station (ICS) units (Model MS26800) that were equipped with Edifier speakers (Model MS34036) shipped in or after April 2023. These speakers may fail to sound audible patient alarms when configured in analog mode. If an alarm does not sound, hospital staff may not be alerted to changes in a patient's condition, which could lead to delayed medical treatment. To date, no incidents or injuries have been reported.
The speakers may fail to annunciate critical visual and audible alarms for physiologic parameters in neonatal, pediatric, and adult patients. This failure can cause medical staff to miss life-threatening changes in a patient's status, potentially resulting in serious harm or death due to delayed clinical intervention.
Recall primarily concerns Edifier Speaker Model MS34036 when used with the Infinity CentralStation workstation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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