Brand Name: The Guardian System Product Name: The recall
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac…
Why was Brand Name: The Guardian System Product Name: The recalled?
Device reaching End of Service prematurely.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac…
- Recalling firm
- Angel Medical Systems, Inc.
- Quantity
- 548 units
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, FL, GA, IN, LA, NV, OK, SC, TX.
- Recall date
- February 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)