FDAFDA · Food and drugs·Recall number Z-2392-2020
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.
Published June 24, 2020 · Recall initiated: April 27, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Defibtech, LLC
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
- Lot
- 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 4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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