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ZOLL Medical Corporation recalls Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for
Recalled September 26, 2012 · FDA recall Z-2401-2012 · ZOLL Medical
Hazard
Shipped with incorrect software · FDA Class II
Units
11 units
Sold at
Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
Description
Shipped with incorrect software
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).
Manufacturer(s)
ZOLL Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →