Device recall
Z-0658-2013: AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA…
FDA device recall · Class II · Zoll Circulation, Inc.
Key facts
| Recall number (Z-number) | Z-0658-2013 |
|---|---|
| Recall event | 62950 |
| Product | AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse. |
| Product code | DRM |
| Recalling firm | Zoll Circulation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2014 |
| 510(k) numbers | K011046, K022345, K032852, K040453 |
| 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