FDA Device

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 uncon

Hazard

Shipped with incorrect software

What You Should Do

Remedy

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.

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Products

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
Brand
ZOLL Medical Corporation
UPC
Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944  AR12F001100, AR12F001298.

Units Affected

11 units

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