Device recall
Z-1533-2025: Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT…
FDA device recall · Class I · ZOLL Circulation, Inc.
Key facts
| Recall number (Z-number) | Z-1533-2025 |
|---|---|
| Recall event | 96479 |
| Product | Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that… |
| Product code | DRM |
| Recalling firm | ZOLL Circulation, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K221700 |
| FEI number | 3003793491 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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