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Angel Medical Systems, Inc. recalls Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The
Recalled February 19, 2025 · FDA recall Z-1140-2025 · Angel Medical Systems
Hazard
Device reaching End of Service prematurely. · FDA Class II
Units
548 units
Sold at
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
Description
Device reaching End of Service prematurely.
Product
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.
Manufacturer(s)
Angel Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →