AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mecha
FDA device recall Z-0658-2013 · posted 2013-01-09 · Terminated
Recall details
- Recalling firm
- Zoll Circulation, Inc.
- Reason for recall
- Complaints associated with an unexpected stop in AutoPulse compressions.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DRM
- Quantity affected
- 3881 in US, 1846 ROW.
- Distribution
- Worldwide distribution.
- Date initiated
- 2012-08-08
- Date posted
- 2013-01-09
- Date terminated
- 2014-05-12
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOPULSE RESUSCITATION SYSTEM MODEL100 (K063602) | Zoll Circulation | 2006-12-21 |
| AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K040453) | Revivant Corp. | 2004-03-11 |
| MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 (K032852) | Revivant Corp. | 2003-11-12 |
| AUTOPULSE RESUSCITATION SYSTEM (K022345) | Revivant Corp. | 2002-08-15 |
| AUTOPULSE, MODEL 100 (K011046) | Revivant Corp. | 2001-10-25 |