PlainRecalls
FDA Devices Moderate Class II Terminated

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 un

Reported: September 26, 2012 Initiated: August 16, 2012 #Z-2401-2012

Product Description

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).

Reason for Recall

Shipped with incorrect software

Details

Recalling Firm
ZOLL Medical Corporation
Units Affected
11 units
Distribution
Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
Location
Chelmsford, MA

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by ZOLL Medical Corporation. Units affected: 11 units.
Why was this product recalled? ▼
Shipped with incorrect software
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2401-2012.

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