Recall Z-2401-2012 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrh
| Date | Sep 17, 2012 (initiated Aug 16, 2012) |
| Status | Terminated |
| Reason | Shipped with incorrect software |
| Root cause | Process control |
| Action | Zoll Medical telephoned affected customers on August 16, 2012. Customers were informed of the affected product, problem and actions to be taken. Customers were instructed to remove and return the affected product for replacement. For question contact ZOLL's Technical Support. |
| Quantity | 11 units |
| Distribution | Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112432 | ZOLL X SERIES Zoll Medical Corporation, World Wide Headquarters, Mar 21, 2012 |