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).
FDA Recall Z-2401-2012 · Posted 2012-09-17
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Recalling FirmZOLL Medical Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2012-08-16
Date Terminated2012-09-19
Product Quantity11 units
Reason for Recall
Shipped with incorrect software
Firm Action
Zoll Medical telephoned affected customers on August 16, 2012. Customers were informed of the affected product, problem and actions to be taken. Customers were instructed to remove and return the affected product for replacement. For question contact ZOLL's Technical Support.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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