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.
Reported: February 19, 2025 Initiated: September 1, 2023 #Z-1140-2025
Product Description
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.
Reason for Recall
Device reaching End of Service prematurely.
Details
- Recalling Firm
- Angel Medical Systems, Inc.
- Units Affected
- 548 units
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Angel Medical Systems, Inc.. Units affected: 548 units.
Why was this product recalled? ▼
Device reaching End of Service prematurely.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2025. Severity: Moderate. Recall number: Z-1140-2025.
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