26

Sep

2012

Zoll X Series Defibrillator/Pacemaker/MonitorCl ll

0

Company:Zoll Medical Corp.
Date of Enforcement Report 9/26/12
Class ll:

PRODUCT

Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: 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 X 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 X Series may be used for the monitoring a patients electrocardiogram (ECG). Recall Number Z-2401-2012

REASON
Shipped with incorrect software

RECALLING FIRM/MANUFACTURER
Zoll Medical Corp., Chelmsford, MA on 8/16/2012. Voluntary: Firm Initiated recallhas been terminated.

VOLUME OF PRODUCT IN COMMERCE
11 units

DISTRIBUTION
Nationwide and Germany

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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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