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U.S. Department of Health and Human Services

Class 2 Device Recall Zoll Medical

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  Class 2 Device Recall Zoll Medical see related information
Date Initiated by Firm August 16, 2012
Date Posted September 17, 2012
Recall Status1 Terminated 3 on September 19, 2012
Recall Number Z-2401-2012
Recall Event ID 63004
510(K)Number K112432  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product 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).
Code Information Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944  AR12F001100, AR12F001298.
Recalling Firm/
Manufacturer		 ZOLL Medical Corporation
269 Mill Road
Chelmsford MA 01824
For Additional Information Contact
978-421-9655
Manufacturer Reason
for Recall		 Shipped with incorrect software
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 11 units
Distribution Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
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