Recall Z-2294-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation
Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 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 tachyc
| Date | May 25, 2011 (initiated Apr 21, 2011) |
| Status | Terminated |
| Reason | Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy |
| Root cause | Software design |
| Action | The firm, Zoll, sent an "Urgent Medical Device Correction" letter dated April 22, 2011 via UPS to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately alert all E Series BLS users to this problem; instruct users to not touch patient and keep the patient still during ECG analysis, Instruct users that if they experience this problem, to press the Analyze button again, and contact ZOLL Technical Service for the software upgrade kit. The letter also states that affected units can remain in service until the software has bee |
| Quantity | 874 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Finland, Germany, Malaysia and 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 |