FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1140-2025
·
Reported February 19, 2025
Enforcement
- Recall Number
- Z-1140-2025
- Event ID
- 96126
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Angel Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 19, 2025
- Initiation Date
- September 1, 2023
- Classification Date
- February 11, 2025
- Address
- 40 Christopher Way Ste 201, Eatontown, NJ, 07724-3327, United States
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
Device reaching End of Service prematurely.
Code Info
Model: AMSG3-E; UDI-DI: 00850012625001; Battery Lots A1946, A1947, A1948, A1949, A1950, A2003, A2004, A2031, A2032, A2033, A2034, A2035, A2036, A2038, A2039, A2040, A2041, A2042, A2043.
Distribution
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
Quantity
548 units