FDAFDA · Food and drugs·Recall number Z-2401-2012
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).
Published September 26, 2012 · Recall initiated: August 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Shipped with incorrect software
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- ZOLL Medical Corporation
- Distributor
- Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
- Lot
- Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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