FDA-Device2025-02-19Class II
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.
Angel Medical Systems, Inc.
Hazard
Device reaching End of Service prematurely.
Sold states
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
Affected count
548 units
Manufactured in
40 Christopher Way Ste 201, Eatontown, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1140-2025Don't want to check this manually?
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