Recall Z-1547-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation, World Wide Headquarters
ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
| Date | May 7, 2010 (initiated Mar 24, 2010) |
| Status | Terminated |
| Reason | Device issued Shock Advised message but failed to auto-charge the defibrillator. |
| Root cause | Software design |
| Action | Zoll Medical Corporation issued an "Urgent Medical Device Correction" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded. For further information, contact Zoll Medical Corporation 24/7 Technical Support at 1-800-348-9011 or 1-978-421-9460. |
| Quantity | 1383 units |
| Distribution | Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042007 | ZOLL E SERIES DEFIBRILLATOR Zoll Medical Corp, Apr 7, 2005 |