Device recall
Z-1904-2011: Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085…
FDA device recall · Class III · Zoll Circulation, Inc.
Key facts
| Recall number (Z-number) | Z-1904-2011 |
|---|---|
| Recall event | 58099 |
| Product | Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs. |
| Product code | DRM |
| Recalling firm | Zoll Circulation, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 28, 2011 |
| 510(k) numbers | K072527 |
| 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