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U.S. Department of Health and Human Services

Class 2 Device Recall Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor

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  Class 2 Device Recall Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor see related information
Date Initiated by Firm March 05, 2014
Date Posted March 31, 2014
Recall Status1 Terminated 3 on January 29, 2021
Recall Number Z-1311-2014
Recall Event ID 67749
510(K)Number K112432  K112761  K121367  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Code Information System Software Version 02.10.02.00 or Higher
Recalling Firm/
Manufacturer		 ZOLL Medical Corporation
269 Mill Road
Chelmsford MA 01824
For Additional Information Contact
978-421-9655
Manufacturer Reason
for Recall		 Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
FDA Determined
Cause 2		 Software design
Action Zoll Medical issued a Notification letter daetd March 5, 2014, to all affected consignees. The notification letter provides information on how to avoid the issue and instructs customers to contact ZOLL to get affected devices updated. Customers will be given the option to have a software upgrade kit sent to them to update their devices or return devices to ZOLL Service department in Chelmsford Massachusetts to have the device upgraded with the latest software release (Software version 02.16.04.00). Customers with questions were instructed to contact the 24/7 technical support numbers 1 (800) 348 9011 or +1 (978) 421 9460 to assist users with any aspect of this notice.
Quantity in Commerce 3,169 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, Afganistian, Australia, Belgium, Czech Republic , China, Chile, Croatia, Denmark, France, Great Britain, Hungary, Israel, Italy, Japan, Korea, Kuwait, Russia, Saudi Arabia, Singapore, South Africa,Thailand, and Turkey.
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
510(K)s with Product Code = MKJ and Original Applicant = ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
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