Device recall
Z-1140-2025: Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number…
FDA device recall · Class II · Angel Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1140-2025 |
|---|---|
| Recall event | 96126 |
| 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… |
| Product code | QBI |
| Recalling firm | Angel Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P150009 |
| FEI number | 3017374019 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database