Company:ZOLL Medical Corp.
Date of Enforcement Report 5/19//2010
Class:ll
PRODUCT
ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Recall # Z-1547-2010
REASON
Device issued Shock Advised message but failed to auto-charge the defibrillator.
RECALLING FIRM/MANUFACTURER
ZOLL Medical Corp., World Wide Headquarters, Chelmsford, MA, by letter dated March 26, 2010. Firm initiated Recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1383 units (957 US, 426 OUS)
DISTRIBUTION
Nationwide, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom
