May

2010

ZOLL E Series Defibrillator/Pacemaker/MonitorCl Il

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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ZOLL E Series Defibrillator/Pacemaker/MonitorCl Il

Amy Sellers

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