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).
This recall has been terminated (originally issued September 17, 2012).
- Company
- Zoll Medical Corporation
- Recall Initiated
- August 16, 2012
- Posted
- September 17, 2012
- Terminated
- September 19, 2012
- Recall Number
- Z-2401-2012
- Quantity
- 11 units
- Firm Location
- Chelmsford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Shipped with incorrect software
Distribution
Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
Lot / Code Info
Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298.
Root Cause
Process control
Action Taken
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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