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U.S. Department of Health and Human Services

Class 2 Device Recall ZOLL R Series Defibrillator/Pacemaker/Monitor

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  Class 2 Device Recall ZOLL R Series Defibrillator/Pacemaker/Monitor see related information
Date Initiated by Firm August 31, 2009
Date Posted September 29, 2009
Recall Status1 Terminated 3 on May 30, 2012
Recall Number Z-2315-2009
Recall Event ID 53162
510(K)Number K060559  
Product Classification Automated External Defibrillators - Product Code MKJ
Product ZOLL R Series Defibrillator/Pacemaker/Monitor

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.
Code Information Serial numbers: AF07F001253 AF07I002116 AF08A003438 AF08D004586 AF08F005082 AF08F005110 AF08G005269 AF08H005383 AF08I005615 AF08I005627 AF08I005646 AF08I005659 AF08I005709 AF08J005735 AF08J005757 AF08J005768 AF08J005776 AF08K005996 AF08K006000 AF08K006007 AF08K006017 AF08K006053 AF08K006102 AF08L006282 AF08L006358 AF08L006359 AF08L006397 AF08L006412 AF08L006442 AF08L006447 AF08L006457 AF08L006462 AF08L006501 AF08L006503 AF08L006508 AF08L006512 AF08L006514 AF08L006515 AF08L006516 AF08L006517 AF08L006518 AF08L006519 AF08L006520 AF08L006521 AF08L006522 AF08L006524 AF08L006528 AF08L006530 AF08L006531 AF08L006532 AF08L006533 AF08L006534 AF08L006535 AF08L006545 AF08L006546 AF08L006547 AF08L006551 AF08L006556 AF08L006558 AF08L006559 AF08L006560 AF08L006565 AF08L006568 AF08L006574 AF08L006575 AF08L006577 AF08L006578 AF08L006579 AF08L006580 AF08L006582 AF08L006583 AF08L006584 AF08L006585 AF08L006586 AF08L006587 AF08L006589 AF08L006590 AF08L006591 AF08L006592 AF08L006593 AF08L006594 AF08L006596 AF08L006598 AF08L006599 AF08L006600 AF08L006601 AF08L006603 AF08L006604 AF08L006605 AF08L006606 AF08L006607 AF08L006609 AF08L006610 AF08L006611 AF08L006612 AF08L006613 AF08L006614 AF08L006619 AF08L006620 AF08L006621 AF08L006622 AF08L006624 AF08L006625 AF08L006626 AF08L006627 AF08L006628 AF09B006680 AF09B006681 AF09B006682 AF09B006684 AF09B006685 AF09B006686 AF09B006688 AF09B006690 AF09B006709 AF09B006712 AF09B006714 AF09B006715 AF09B006716 AF09B006718 AF09B006724 AF09B006726 AF09B006727 AF09B006728 AF09B006732 AF09B006736 AF09B006737 AF09B006739 AF09B006740 AF09B006744 AF09B006745 AF09B006748 AF09B006761 AF09B006762 AF09B006765 AF09B006766 AF09B006767 AF09B006768 AF09B006770 AF09B006772 AF09B006774 AF09B006775 AF09B006776 AF09B006777 AF09B006778 AF09B006779 AF09B006780 AF09B006781 AF09B006782 AF09B006783 AF09B006784 AF09B006785 AF09B006786 AF09B006787 AF09B006789 AF09B006791 AF09B006794 AF09B006795 AF09B006798 AF09B006799 AF09B006800 AF09B006801 AF09B006802 AF09B006806 AF09B006807 AF09B006808 AF09B006809 AF09B006810 AF09B006811 AF09B006812 AF09B006813 AF09B006814 AF09B006815 AF09B006816 AF09B006818 AF09B006819 AF09B006820 AF09B006821 AF09B006824 AF09B006825 AF09B006827 AF09B006828 AF09B006830 AF09B006831 AF09B006832 AF09B006834 AF09B006836 AF09B006837 AF09B006838 AF09B006839 AF09B006840 AF09B006841 AF09B006842 AF09B006844 AF09B006845 AF09B006846 AF09B006847 AF09B006859 AF09B006860 AF09B006861 AF09C006880 AF09C006881 AF09C006883 AF09C006884 AF09C006888 AF09C006894 AF09C006895 AF09C006896 AF09C006899 AF09C006905 AF09C006912 AF09C006915 AF09C006928 AF09C006929 AF09C006930 AF09C006931 AF09C006932 AF09C006933 AF09C006934 AF09C006937 AF09C006939 AF09C006940 AF09C006942 AF09C006956 AF09C006957 AF09C006958 AF09C006959 AF09C006960 AF09C006961 AF09C006962 AF09C006964 AF09C006968 AF09C007103 AF09C007104 AF09C007106 AF09C007107 AF09C007108 AF09C007109 AF09C007110 AF09C007111 AF09C007130 AF09C007132 AF09C007194 AF09C007200 AF09C007427 AF09D007485, and AF09F007805. 
Recalling Firm/
ZOLL Medical Corporation, World Wide Headquarters
269 Mill Rd
Chelmsford MA 01824
For Additional Information Contact SAME
978-421-9655 Ext. 413
Manufacturer Reason
for Recall
Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Zoll notified domestic consignees on August 31, 2009 and international consignees on September 1, 2009 by an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily tests per the recommendations provided in the R Series Operator's Guide. In the event of a failure, customers are to remove the device from service and contact biomedical or clinical engineering department per their facility's protocol. Units that operate as expected can remain in service and back-up monitor should be available in the event of a failure. Zoll's technical support department should be contacted at 1-800-348-9011 or +1-978-421-9460 to schedule the return of affected devices with the defect for replacement of the suspect component.
Quantity in Commerce 247 units
Distribution Worldwide Distribution -- USA, UK, Austria, Australia,, Canada, Switzerland, Germany, France, French Guiana, Jordan, Macedonia, Netherlands, Panama, Poland, Romania, and Saudi Arabia.
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