Recall Z-0658-2013 ยท DRM Compressor, Cardiac, External
Zoll Circulation, Inc.
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.
| Date | Jan 9, 2013 (initiated Aug 8, 2012) |
| Status | Terminated |
| Reason | Complaints associated with an unexpected stop in AutoPulse compressions. |
| Root cause | Employee error |
| Action | Zoll sent Customer Notification letters dated August 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Zoll Technical Support Line at 1 (800) 348-9011 for further assistance. |
| Quantity | 3881 in US, 1846 ROW. |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011046 | AUTOPULSE, MODEL 100 Revivant Corp., Oct 25, 2001 |
| K022345 | AUTOPULSE RESUSCITATION SYSTEM Revivant Corp., Aug 15, 2002 |
| K032852 | MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 Revivant Corp., Nov 12, 2003 |
| K040453 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 Revivant Corp., Mar 11, 2004 |
| K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 Zoll Circulation, Dec 21, 2006 |