Recall Z-1140-2025— Angel Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Angel Medical Systems, Inc., initiated 2023-09-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Angel Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-01
- Firm location
- Eatontown, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.