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U.S. Department of Health and Human Services

Class 2 Device Recall Lifeline, ReviveR

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  Class 2 Device Recall Lifeline, ReviveR see related information
Date Initiated by Firm April 27, 2020
Create Date June 17, 2020
Recall Status1 Terminated 3 on January 08, 2021
Recall Number Z-2392-2020
Recall Event ID 85702
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN

Catalog Numbers CCD-A1006RX
CCD-A1013EN
CCD-A1015EN
DCF-A2310EN
DCF-A2310RX
DCF-A2313EN
DCF-C2310CA
DCF-C2310EN
DCF-E2310CA
DCF-E2310EN

UDI 00815098020201,
00815098020225, 00815098020232
Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
Code Information Serial Numbers: 400086354 400086358 400090005 400091761 400093477 400093478 400093479 400093480 400093481 400093482 400093483 400093484 400093485 400093486 400093487 400093488 400093489 400093490 400093491 400093492 400093493 400093494 400093495 400093496 400093497 400093498 400093499 400093500 400093501 400093502 400093503 400093504 400093505 400093506 400093508 400093510 400093512 400093513 400093514 400093515 400093516 400093517 400093518 400093519 400093520 400093521 400093522 400093523 400093524 400093525 400093527 400093528 400093529 400093530 400093531 400093532 400093533 400093534 400093535 400093536 400093538 400093539 400093540 400093541 400093542 400093543 400093544 400093545 400093546 400093547 400093548 400093549 400093550 400093551 400093552 400093553 400093554 400093555 400093556 400093557 400094155 400098786 400098812 400101171 400101172 400101174 400101175 400101176 400101177 400101178 400101179 400101180 400101181 400101182 400101183 400101184 400101185 400101186 400101187 400101188 400101189 400101190 400101191 400101192 400101193 400101194 400101195 400101196 400101197 400101198 400101199 400101200 400101203 400101204 400101205 400101207 400101208 400101209 400101213 400101214 400101217 400101218 400101219 400101220 400101221 400101222 400101223 400101225 400101226 400101227 400101229 400101230 400101231 400101236 400101237 400101238 400101240 400101241 400101242 400101244 400101245 400101246 400101247 400101248 400101250 400101251 400101252 400101253 400101254 400101255 400101256 400101257 400101258 400101259 400101260 400101261 400101262 400101263 400101264 400101265 400101266 400101267 400101268 400101575 400101576 400101577 400101578 400101579 400101580 400101581 400101582 400101583 400101584 400101585 400101587 400101588 400101589 400101590 400101591 400101592 400101593 400101594 400101595 400101596 400101597 400101598 400101600 400101601 400101602 400101603 400101604 400101605 400101606 400101607 400101608 400101609 400101611 400101612 400101613 400101614 400101616 400101618 400101620 400101621 400101622 400101623 400101624 400101625 400101626 400101627 400101628 400101629 400101630 400101631 400101632 400101633 400101634 400101635 400101636 400101638 400101639 400101640 400101641 400101642 400101643 400101644 400101645 400101646 400101647 400101648 400101649 400101650 400101651 400101652 400101654 400101656 400101657 400101658 400101659 400101660 400101661 400101662 400101663 400101664 400101665 400101666 400101667 400101668 400101670 400101671 400101672 400101673 400101674 400101677 400101678 400101679 400101681 400101682 400101683 400101684 400101685 400101686 400101687 400101688 400101689 400101690 400101691 400101692 400101693 400101694 400101695 400101696 400101697 400101698 400101699 400101701 400101702 400101703 400101704 400101705 400101707 400101708 400101709 400101710 400101711 400101712 400101713 400101714 400101715 400101716 400101718 400101719 400101721 400101722 400101723 400101724 400101726 400101727 400101728 400101730 400101731 400101732 400101733 400101734 400101735 400101736 400101737 400101738 400101739 400101740 400101741 400101742 400101743 400101744 400101745 400101746 400101747 400101748 400101750 400101751 400101752 400101753 400101754 400101756 400101757 400101759 400101760 400101761 400101762 400101763 400101764 400101765 400101766 400101767 400101768 400101769 400101770 400101771 400101772 400101773 400101774 400101776 400101777 400101778 400101779 400101780 400101781 400101782 400101783 400101784 400101785 400101786 400101787 400101788 400101789 400101790 400101791 400101792 400101793 400101794 400101795 400101796 400101797 400101798 400101799 400101801 400101802 400101803 400101804 400101805 400101806 400101807 400101808 400101809 400101810 400101811 400101812 400101813 400101814 400101815 400101816 400101817 400101818 400101924 400101925 400101926 400101927 400101928 400101929 400101930 400101931 400101932 400101934 400101935 400101936 400101938 400101989 400101992 400101998 400125000 400125001 400125003 400125004 400125005 400125006 400125007 400125009 400125010 400125011 400125012 400125014 400125015 400125016 400125195 400125196 400125197 400125198 400125200 400125202 400125203 400128005 400128037 400128040 400128049 400128050 400128052 400128053 400128055 400128056 400128057 400128058 400128059 400128060 400128061 400128062 400128063 400128064 400128065 400128066 400128067 400128068 400128069 400128070 400128071 400128072 400128073 400128075 400128076 400128077 400128078 400128079 400128080 400128081 400128082 400128083 400128084 400128085 400128086 400128087 400128088 400128089 400128090 400128091 400128092 400128093 400128094 400128095 400128096 400128097 400128098 400128099 400128100 400128101 400128103 400128104 400128105 400128106 400128107 400128108 400128109 400128110 400128111 400128112 400128113 400128114 400128115 400128116 400128118 400128119 400128120 400128121 400128122 400128123 400128124 400128125 400128126 400128127 400128128 400128129 400128130 400128131 400128132 400128133 400128134 400128135 400128136 400128137 400128138 400128139 400128140 400128141 400128142 400128143 400128144 400128145 400128146 400128147 400128148 400128151 400128152 400128153 400128154 400128155 400128156 400128157 400128158 400128160 400128161 400128162 400128163 400128164 400128165 400128166 400128168 400128169 400128170 400128171 400128172 400128258 400128278 400128306 400131106 400131154 400131155 400131157 400131165 400131169 400131176 400131182 400131188 400131195 400131197 400131198 400131199 400131200 400131205 400131207 400131243 400131244 400131245 400131246 400131255 400131264 400131276 400131277 400131278 400131279 400131280 400131281 400131282 400131283 400131284 400131285 400131286 400131287 400131289 400131290 400131291 400131292 400131293 400131294 400131295 400131296 400131297 400131298 400131299 400131300 400131301 400131302 400131303 400131304 400131305 400131306 400131307 400131308 400131309 400131310 400131311 400131312 400131313 400131314 400131315 400131317 400131318 400131319 400131320 400131321 400131322 400131323 400131324 400131325 400131326 400131327 400131328 400131329 400131330 400131331 400131332 400131333 400131334 400131335 400131336 400131337 400131338 400131339 400131340 400131341 400131343 400131344 400131345 400131346 400131347 400131348 400131349 400131350 400131352 400131353 400131354 400131355 400131357 400131358 400131359 400131361 400131362 400131363 400131364 400131365 400131366 400131367 400131368 400131369 400131370 400131371 400131373 400131376 400131377 400131378 400131379 400131380 400131381 400131383 400131384 400131385 400131386 400131387 400131388 400131389 400131390 400131391 400131392 400131393 400131394 400131395 400131396 400131397 400131399 400131401 400131402 400131403 400131404 400131405 400131406 400131407 400131409 400131410 400131412 400131413 400131414 400131415 400131416 400131417 400131418 400131419 400131420 400131421 400131424 400131425 400131426 400131427 400131428 400131429 400131430 400131432 400131433 400131434 400131435 400131436 400131437 400131438 400131439 400131440 400131441 400131442 400131443 400131444 400131445 400131446 400131447 400131448 400131449 400131451 400131452 400131453 400131454 400131455 400131456 400131457 400131458 400131459 400131460 400131461 400131463 400131464 400131466 400131467 400131468 400131469 400131470 400131471 400131472 400131473 400131474 400131475 400131476 400131477 400131478 400131479 400131480 400131481 400131482 400131483 400131484 400131485 400131486 400131487 400131489 400131490 400131491 400131492 400131493 400131494 400131495 400131496 400131507 400131508 
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd
Suite 201
Guilford CT 06437-2714
For Additional Information Contact Defibtech Customer Service
203-453-6654 Ext. 2
Manufacturer Reason
for Recall		 A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
FDA Determined
Cause 2		 Component design/selection
Action The firm contacted affected customers via email and mailed letter on April 27, 2020. Distributors were asked to forward letters to end users. Customers were informed that affected products may abort a shock delivery or reset unexpectedly. Customers were asked to return all affected products for screening. Actions to be taken by the Customer/User: 1. If you have additional AEDs on hand , please quarantine and return any affected units as identified in the Attachment for screening or replacement. Do not include the pads and battery packs when you return your unit. 2. If no other AEDs are available, please continue using the device with caution until a loaner or replacement is provided. 3. Ensure that all users of the AED are informed of the product issue. Defibtech will provide support for handling all aspects of the return of identified units for screening. The firm will contact customers to help them with the process. If you have questions now, please contact the firm using the email address FA2020@defibtech.com. Additionally, Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday.
Quantity in Commerce 860
Distribution Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
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.
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