Draeger Medical Systems is recalling approximately 34,102 Infinity Acute Care System (IACS) Monitoring Systems, specifically the Infinity M500 with Power (Model MS20407, Revisions 20, 21, and 23). The devices do not meet required electrical safety standards for Type CF medical equipment. This defect can lead to dangerous electrical malfunctions during patient monitoring, which may result in electric shocks, burns, or life-threatening heart rhythm issues. These units were distributed nationwide and internationally to healthcare facilities.
The device's internal components do not provide adequate electrical insulation required by safety standards, creating a potential path for electrical current to reach the patient or healthcare provider. This can cause physical burns, electrical shock, and serious cardiac arrhythmia if the current interferes with the patient's heart function.
Manufacturer Notification and Guidance
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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