Z-1140-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2025
- Initiation Date
- September 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 548 units
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.
Distribution Pattern
US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
Code Information
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.