Company:ZOLL Medical Corp.
Date of Enforcement Report 6/1/2011
Class ll:
PRODUCT
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 tachycardias and other arrhythmias resistant to drug therapy. The E Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The E Series may be used for the monitoring a patients electrocardiogram (ECG). Recall # Z-2294-2011
REASON
Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy.
RECALLING FIRM/MANUFACTURER
ZOLL Medical Corp., Chelmsford, MA, by letter dated April 22, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
874 units
DISTRIBUTION
Nationwide and countries of: Australia, Canada, Finland, Germany, Malaysia and United Kingdom