• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zoll

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Zoll see related information
Date Initiated by Firm April 21, 2011
Date Posted May 25, 2011
Recall Status1 Terminated 3 on January 23, 2014
Recall Number Z-2294-2011
Recall Event ID 58600
510(K)Number K042007  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Zoll E Series BLS Defibrillator/Pacemaker/Monitor
Software versions 7.10 and 7.11

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 E 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 E Series may be used for the monitoring a patients electrocardiogram (ECG).
Code Information Serial Numbers: AB05D000033 AB05F000398 AB05F000405 AB05F000425 AB05F000426 AB05F000430 AB05F000437 AB05F000446 AB05F000448 AB05F000450 AB05F000451 AB05F000456 AB05F000463 AB05F000465 AB05F000466 AB05F000468 AB05F000469 AB05F000470 AB05F000471 AB05F000474 AB05F000482 AB05F000483 AB05F000484 AB05F000485 AB05F000511 AB05F000512 AB05I000666 AB05I000668 AB05I000669 AB05I000670 AB05I000673 AB05I000675 AB05L000906 AB05L000909 AB05L000911 AB05L000920 AB05L000943 AB05L000944 AB05L000945 AB06A000960 AB06A000961 AB06A000964 AB06A000966 AB06A000974 AB06A000987 AB06A000989 AB06A000990 AB06A000994 AB06B001071 AB06B001091 AB06B001093 AB06B001094 AB06B001096 AB06B001110 AB06B001124 AB06B001163 AB06B001181 AB06C001211 AB06C001267 AB06C001275 AB06C001276 AB06C001277 AB06C001336 AB06C001337 AB06C001338 AB06C001339 AB06C001343 AB06C001344 AB06C001346 AB06C001364 AB06D001422 AB06D001431 AB06D001434 AB06D001437 AB06D001439 AB06D001442 AB06D001450 AB06D001582 AB06E001647 AB06E001649 AB06E001650 AB06E001653 AB06E001654 AB06E001708 AB06E001709 AB06F001722 AB06F001723 AB06F001796 AB06F001883 AB06F001914 AB06F001916 AB06G002052 AB06G002057 AB06G002093 AB06G002096 AB06G002099 AB06G002100 AB06G002120 AB06G002124 AB06H002132 AB06H002133 AB06H002134 AB06H002153 AB06H002177 AB06H002264 AB06H002266 AB06I002353 AB06I002363 AB06I002441 AB06I002452 AB06I002539 AB06I002540 AB06I002655 AB06I002673 AB06I002675 AB06I002692 AB06I002695 AB06I002706 AB06I002709 AB06I002715 AB06I002737 AB06J002757 AB06J002778 AB06J002780 AB06J002785 AB06J002786 AB06J002787 AB06J002788 AB06J002789 AB06J002792 AB06J002793 AB06J002797 AB06J002834 AB06J002848 AB06J002850 AB06J002925 AB06J002928 AB06J002929 AB06J002931 AB06L003172 AB06L003204 AB06L003205 AB06L003206 AB06L003209 AB06L003271 AB06L003323 AB07A003370 AB07A003458 AB07A003459 AB07A003460 AB07A003464 AB07A003466 AB07A003470 AB07B003668 AB07B003669 AB07B003672 AB07B003673 AB07C003681 AB07C003690 AB07C003691 AB07C003696 AB07C003699 AB07C003700 AB07C003707 AB07C003708 AB07C003709 AB07C003710 AB07C003716 AB07C003720 AB07C003727 AB07C003921 AB07D003967 AB07D003974 AB07D003976 AB07D003979 AB07D003991 AB07E004157 AB07E004159 AB07E004160 AB07E004180 AB07E004197 AB07E004318 AB07E004391 AB07E004392 AB07E004398 AB07F004436 AB07F004437 AB07F004438 AB07F004439 AB07F004440 AB07F004449 AB07F004471 AB07F004472 AB07F004473 AB07F004474 AB07F004488 AB07F004490 AB07F004563 AB07F004565 AB07F004567 AB07F004568 AB07F004576 AB07F004619 AB07F004621 AB07F004624 AB07F004655 AB07F004735 AB07F004736 AB07G004757 AB07G004773 AB07G004787 AB07G004789 AB07G004799 AB07G004921 AB07G004923 AB07G004927 AB07G004928 AB07G004930 AB07H004999 AB07H005008 AB07H005133 AB07H005139 AB07H005146 AB07I005227 AB07I005231 AB07I005236 AB07I005237 AB07I005240 AB07I005258 AB07I005265 AB07I005395 AB07I005476 AB07I005479 AB07I005484 AB07I005516 AB07I005517 AB07I005585 AB07I005588 AB07I005607 AB07J005689 AB07J005765 AB07J005784 AB07K005881 AB07K005938 AB07L005974 AB07L006036 AB07L006038 AB07L006039 AB07L006040 AB07L006042 AB07L006044 AB07L006045 AB07L006048 AB07L006072 AB07L006075 AB07L006077 AB07L006116 AB07L006117 AB07L006122 AB07L006124 AB07L006126 AB07L006129 AB07L006131 AB07L006154 AB07L006157 AB07L006194 AB08A006246 AB08A006251 AB08A006252 AB08A006258 AB08A006260 AB08A006262 AB08A006290 AB08A006299 AB08A006304 AB08A006306 AB08A006308 AB08A006320 AB08A006322 AB08A006334 AB08A006387 AB08A006392 AB08B006498 AB08B006698 AB08B006704 AB08C006722 AB08C006731 AB08C006732 AB08C006792 AB08C006793 AB08C006813 AB08C006824 AB08C006848 AB08C006887 AB08C006888 AB08C006889 AB08C006916 AB08C006923 AB08C006925 AB08C006934 AB08C006935 AB08C006937 AB08D006955 AB08D006964 AB08D006966 AB08D006967 AB08D006975 AB08D006976 AB08D006978 AB08D006982 AB08D007061 AB08D007069 AB08D007138 AB08D007146 AB08E007227 AB08E007240 AB08E007250 AB08E007412 AB08F007457 AB08F007458 AB08F007459 AB08F007461 AB08F007466 AB08F007476 AB08F007483 AB08F007517 AB08F007530 AB08F007546 AB08F007572 AB08F007590 AB08F007597 AB08F007599 AB08F007604 AB08F007605 AB08F007606 AB08F007612 AB08F007618 AB08F007621 AB08F007626 AB08F007634 AB08F007635 AB08G007698 AB08G007699 AB08G007702 AB08G007707 AB08G007709 AB08G007715 AB08G007719 AB08G007728 AB08G007732 AB08G007758 AB08G007786 AB08G007822 AB08G007835 AB08G007889 AB08G007891 AB08G007897 AB08H007906 AB08H007910 AB08H007993 AB08H008034 AB08H008035 AB08H008039 AB08H008081 AB08H008118 AB08I008171 AB08I008174 AB08I008175 AB08I008187 AB08I008197 AB08I008208 AB08I008210 AB08I008383 AB08I008401 AB08I008434 AB08I008525 AB08I008532 AB08I008624 AB08I008629 AB08I008631 AB08I008640 AB08J008683 AB08J008695 AB08J008696 AB08J008701 AB08J008705 AB08J008836 AB08J008840 AB08J008846 AB08K008863 AB08K008864 AB08K008894 AB08K008896 AB08K008898 AB08K008899 AB08K008900 AB08K008902 AB08K008904 AB08K008909 AB08K008910 AB08K008917 AB08K008919 AB08K008920 AB08K008921 AB08K008922 AB08K008923 AB08K008924 AB08K008928 AB08K008929 AB08K008947 AB08K008948 AB08K008949 AB08K008974 AB08K008979 AB08K008980 AB08K008981 AB08K008982 AB08K009020 AB08K009021 AB08L009133 AB08L009134 AB08L009160 AB08L009169 AB08L009170 AB08L009172 AB08L009184 AB08L009185 AB08L009228 AB08L009230 AB08L009233 AB08L009234 AB08L009250 AB08L009251 AB09A009285 AB09A009286 AB09A009298 AB09A009301 AB09A009303 AB09A009308 AB09A009311 AB09A009312 AB09A009313 AB09A009314 AB09A009315 AB09A009316 AB09A009317 AB09A009318 AB09A009320 AB09A009321 AB09A009322 AB09A009323 AB09A009324 AB09A009325 AB09A009326 AB09A009327 AB09A009339 AB09A009367 AB09A009382 AB09A009390 AB09A009401 AB09A009405 AB09A009406 AB09A009408 AB09A009424 AB09A009499 AB09A009500 AB09A009505 AB09B009591 AB09B009617 AB09B009650 AB09B009658 AB09B009681 AB09B009683 AB09B009684 AB09B009716 AB09B009717 AB09B009718 AB09B009719 AB09B009720 AB09B009721 AB09B009722 AB09B009723 AB09B009724 AB09B009725 AB09B009731 AB09B009864 AB09B009865 AB09C009945 AB09C009965 AB09C009999 AB09C010082 AB09C010218 AB09C010247 AB09C010267 AB09C010348 AB09C010378 AB09C010379 AB09D010534 AB09D010535 AB09D010537 AB09D010538 AB09D010539 AB09D010541 AB09D010544 AB09D010546 AB09D010551 AB09D010553 AB09D010554 AB09D010653 AB09D010654 AB09D010655 AB09D010656 AB09D010657 AB09D010658 AB09D010659 AB09D010731 AB09D010732 AB09D010733 AB09E010766 AB09E010767 AB09E010768 AB09E010769 AB09E010773 AB09E010774 AB09E010775 AB09E010776 AB09E010834 AB09E010848 AB09E010853 AB09E010884 AB09E010885 AB09E010895 AB09E010916 AB09E010917 AB09E010918 AB09E010920 AB09E010921 AB09E010922 AB09E010923 AB09E010925 AB09E010926 AB09E010929 AB09E010930 AB09E010931 AB09E010932 AB09E010933 AB09F011016 AB09F011018 AB09F011027 AB09F011028 AB09F011030 AB09F011031 AB09F011041 AB09F011045 AB09F011046 AB09F011047 AB09F011051 AB09F011053 AB09F011054 AB09F011057 AB09F011059 AB09F011060 AB09F011064 AB09F011066 AB09F011067 AB09F011073 AB09F011082 AB09F011114 AB09F011116 AB09F011118 AB09F011119 AB09F011120 AB09F011212 AB09F011213 AB09F011214 AB09F011215 AB09F011216 AB09F011217 AB09F011219 AB09F011220 AB09F011221 AB09F011222 AB09G011248 AB09G011249 AB09G011250 AB09G011251 AB09G011252 AB09G011271 AB09G011274 AB09G011277 AB09G011278 AB09G011280 AB09H011406 AB09H011456 AB09H011471 AB09I011714 AB09I011715 AB09I011723 AB09I011726 AB09I011727 AB09I011728 AB09I011729 AB09I011730 AB09I011731 AB09I011733 AB09I011974 AB09I011979 AB09I011980 AB09I011981 AB09I011984 AB09I011985 AB09I011989 AB09I011991 AB09I011992 AB09I011993 AB09I011994 AB09I011995 AB09I011996 AB09I011997 AB09I011999 AB09I012000 AB09I012001 AB09I012002 AB09I012003 AB09I012004 AB09I012005 AB09I012006 AB09I012007 AB09I012008 AB09I012009 AB09I012010 AB09I012011 AB09I012058 AB09I012216 AB09I012218 AB09I012227 AB09I012229 AB09I012241 AB09I012242 AB09J012261 AB09J012268 AB09J012271 AB09J012273 AB09J012274 AB09J012276 AB09J012286 AB09J012288 AB09J012291 AB09J012297 AB09J012299 AB09J012301 AB09J012304 AB09J012305 AB09J012306 AB09J012307 AB09J012308 AB09J012309 AB09J012312 AB09J012313 AB09J012314 AB09J012315 AB09J012316 AB09J012318 AB09J012319 AB09J012320 AB09J012321 AB09J012322 AB09J012323 AB09J012324 AB09J012335 AB09K012504 AB09K012506 AB09K012508 AB09K012510 AB09K012511 AB09K012514 AB09K012516 AB09K012533 AB09K012536 AB09K012538 AB09K012541 AB09K012543 AB09K012547 AB09K012549 AB09K012550 AB09K012553 AB09K012688 AB09K012690 AB09K012691 AB09K012692 AB09K012702 AB09K012703 AB09K012706 AB09L012708 AB09L012709 AB09L012710 AB09L012711 AB09L012712 AB09L012713 AB09L012714 AB09L012715 AB09L012805 AB09L012806 AB09L012816 AB09L012822 AB09L012913 AB09L012921 AB09L012968 AB09L012969 AB09L012970 AB09L012971 AB09L012984 AB09L013002 AB09L013003 AB09L013004 AB09L013005 AB09L013010 AB09L013011 AB09L013025 AB09L013027 AB09L013028 AB09L013031 AB09L013032 AB09L013033 AB09L013034 AB09L013035 AB09L013036 AB09L013037 AB09L013038 AB09L013039 AB09L013040 AB10A013051 AB10A013089 AB10A013101 AB10A013125 AB10A013126 AB10A013148 AB10A013154 AB10A013163 AB10A013183 AB10A013185 AB10A013190 AB10A013191 AB10A013197 AB10A013205 AB10A013218 AB10A013221 AB10A013225 AB10A013241 AB10A013245 AB10A013248 AB10A013249 AB10A013250 AB10A013251 AB10A013252 AB10A013253 AB10A013254 AB10A013288 AB10A013289 AB10A013352 AB10A013355 AB10A013356 AB10A013357 AB10A013358 AB10A013359 AB10A013360 AB10A013361 AB10A013362 AB10A013365 AB10A013380 AB10A013384 AB10A013389 AB10B013411 AB10B013417 AB10B013418 AB10B013428 AB10B013438 AB10B013439 AB10B013458 AB10B013459 AB10B013460 AB10B013483 AB10B013540 AB10B013541 AB10B013542 AB10B013544 AB10B013545 AB10B013546 AB10B013547 AB10B013548 AB10B013549 AB10B013550 AB10B013551 AB10B013552 AB10B013553 AB10B013554 AB10B013555 AB10B013561 AB10B013571 AB10B013572 AB10B013574 AB10B013575 AB10B013576 AB10B013577 AB10B013584 AB10B013585 AB10B013586 AB10C013680 AB10C013681 AB10C013683 AB10C013684 AB10C013686 AB10C013688 AB10C013696 AB10C013697 AB10C013698 AB10C013699 AB10C013700 AB10C013701 AB10C013702 AB10C013703 AB10C013704 AB10C013705 AB10C013706 AB10C013708 AB10C013709 AB10C013710 AB10C013711 AB10C013712 AB10C013713 AB10C013715 AB10C013716 AB10C013717 AB10C013718 AB10C013719 AB10C013764 AB10C013765 AB10C013769 AB10C013770 AB10C013887 AB10C013905 AB10C013906 AB10C013918 AB10C013919 AB10C013925 AB10C013986 AB10C014016 AB10C014017 AB10C014019 AB10C014020 AB10C014021 AB10C014022 AB10C014028 AB10C014049 AB10C014055 AB10C014057 AB10C014058 AB10C014060 AB10D014121 AB10D014122 AB10D014123 AB10D014167 AB10D014171 AB10D014174 AB10D014178 AB10D014179 AB10D014182 AB10D014189 AB10D014196 AB10D014217 AB10D014218 AB10D014219 AB10D014220 AB10D014221 
Recalling Firm/
ZOLL Medical Corporation
269 Mill Road
Chelmsford MA 01824
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy
FDA Determined
Cause 2
Software design
Action The firm, Zoll, sent an "Urgent Medical Device Correction" letter dated April 22, 2011 via UPS to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately alert all E Series BLS users to this problem; instruct users to not touch patient and keep the patient still during ECG analysis, Instruct users that if they experience this problem, to press the Analyze button again, and contact ZOLL Technical Service for the software upgrade kit. The letter also states that affected units can remain in service until the software has been updated. If you have any questions, please contact 24/7 technical support at 1 (800) 348-9011 or +1 (978) 421-9460.
Quantity in Commerce 874 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Finland, Germany, Malaysia and United Kingdom.
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 CORP.