Device recall
Z-1317-2025: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1)…
FDA device recall · Class II · ZOLL Medical Corporation
Key facts
| Recall number (Z-number) | Z-1317-2025 |
|---|---|
| Recall event | 96198 |
| Product | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular… |
| Product code | MKJ |
| Recalling firm | ZOLL Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P160033 |
| FEI number | 1220908 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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