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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart defibrillator

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  Class 2 Device Recall HeartStart defibrillator see related information
Date Initiated by Firm April 30, 2008
Date Posting Updated July 09, 2008
Recall Status1 Terminated 3 on October 23, 2012
Recall Number Z-1779-2008
Recall Event ID 47833
510(K)Number K020715  K040904  
Product Classification Defibrillator - Product Code MKJ
Product Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand name Philips "HeartStart On Site Defibrillator" and outside the U.S. by Philips with the brand name Philips "HeartStart Defibrillator". The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.
Code Information 96 A05I-02397 A05I-02398 A05I-02399 A05I-02400 A05I-02401 A05I-02402 A05I-02403 A05I-02404 A05I-02405 A05I-02406 A05I-02407 A05I-02408 A05I-02409 A05I-02410 A05I-02411 A05I-02412 A05I-02413 A05I-02414 A05I-02415 A05I-02416 A05I-02417 A05I-02418 A05I-02419 A05I-02420 A05I-02421 A05I-02422 A05I-02423 A05I-02424 A05I-02425 A05I-02426 A05I-02427 A05I-02428 A05I-02429 A05I-02430 A05I-02431 A05I-02432 A05I-02433 A05I-02434 A05I-02435 A05I-02436 A05I-02437 A05I-02438 A05I-02439 A05I-02440 A05I-02441 A05I-02442 A05I-02443 A05I-02444 A05I-02445 A05I-02446 A05I-02448 A05I-02449 A05I-02450 A05I-02451 A05I-02452 A05I-02453 A05I-02454 A05I-02455 A05I-02456 A05I-02457 A05I-02458 A05I-02459 A05I-02460 A05I-02461 A05I-02462 A05I-02464 A05I-02466 A05I-02467 A05I-02468 A05I-02469 A05I-02470 A05I-02471 A05I-02472 A05I-02473 A05I-02474 A05I-02475 A05I-02476 A05I-02477 A05I-02478 A05I-02479 A05I-02480 A05I-02481 A05I-02482 A05I-02483 A05I-02484 A05I-02485 A05I-02486 A05I-02487 A05I-02488 A05I-02489 A05I-02490 A05I-02491 A05I-02492 A05I-02493 A05I-02494 A05I-02495 A05I-02496 A05I-02497 A05I-02498 A05I-02499 A05I-02500 A05I-02501 A05I-02502 A05I-02503 A05I-02504 A05I-02505 A05I-02506 A05I-02507 A05I-02508 A05I-02509 A05I-02510 A05I-02511 A05I-02512 A05I-02513 A05I-02514 A05I-02515 A05I-02516 A05I-02517 A05I-02518 A05I-02519 A05I-02520 A05I-02521 A05I-02522 A05I-02523 A05I-02525 A05I-02526 A05I-02527 A05I-02528 A05I-02529 A05I-02530 A05I-02531 A05I-02532 A05I-02533 A05I-02534 A05I-02535 A05I-02536 A05I-02537 A05I-02539 A05I-02540 A05I-02541 A05I-02542 A05I-02543 A05I-02544 A05I-02545 A05I-02546 A05I-02547 A05I-02548 A05I-02549 A05I-02550 A05I-02551 A05I-02552 A05I-02553 A05I-02554 A05I-02555 A05I-02556 A05I-02557 A05I-02558 A05I-02559 A05I-02560 A05I-02561 A05I-02562 A05I-02563 A05I-02564 A05I-02565 A05I-02566 A05I-02567 A05I-02568 A05I-02569 A05I-02570 A05I-02571 A05I-02572 A05I-02573 A05I-02574 A05I-02575 A05I-02576 A05I-02577 A05I-02578 A05I-02579 A05I-02580 A05I-02581 A05I-02582 A05I-02583 A05I-02584 A05I-02585 A05I-02586 A05I-02587 A05I-02588 A05I-02589 A05I-02590 A05I-02591 A05I-02592 A05I-02593 A05I-02594 A05I-02595 A05I-02596 A05I-02597 A05I-02598 A05I-02599 A05I-02600 A05I-02601 A05I-02602 A05I-02603 A05I-02604 A05I-02605 A05I-02606 A05I-02607 A05I-02608 A05I-02609 A05I-02610 A05I-02611 A05I-02612 A05I-02613 A05I-02614 A05I-02615 A05I-02616 A05I-02617 A05I-02618 A05I-02619 A05I-02620 A05I-02621 A05I-02622 A05I-02623 A05I-02624 A05I-02625 A05I-02626 A05I-02627 A05I-02628 A05I-02629 A05I-02630 A05I-02631 A05I-02632 A05I-02633 A05I-02634 A05I-02635 A05I-02636 A05I-02637 A05I-02638 A05I-02639 A05I-02640 A05I-02641 A05I-02642 A05I-02643 A05I-02644 A05I-02645 A05I-02646 A05I-02647 A05I-02648 A05I-02649 A05I-02650 A05I-02651 A05I-02653 A05I-02654 A05I-02656 A05I-02657 A05I-02658 A05I-02659 A05I-02660 A05I-02661 A05I-02662 A05I-02663 A05I-02664 A05I-02665 A05I-02666 A05I-02667 A05I-02668 A05I-02669 A05I-02670 A05I-02671 A05I-02673 A05I-02674 A05I-02675 A05I-02676 A05I-02677 A05I-02678 A05I-02679 A05I-02680 A05I-02681 A05I-02682 A05I-02683 A05I-02684 A05I-02685 A05I-02686 A05I-02687 A05I-02689 A05I-02690 A05I-02691 A05I-02692 A05I-02693 A05I-02694 A05I-02695 A05I-02696 A05I-02697 A05I-02698 A05I-02699 A05I-02700 A05I-02701 A05I-02702 A05I-02703 A05I-02704 A05I-02705 A05I-02706 A05I-02707 A05I-02708 A05I-02709 A05I-02710 A05I-02711 A05I-02712 A05I-02713 A05I-02714 A05I-02715 A05I-02716 A05I-02717 A05I-02719 A05I-02720 A05I-02721 A05I-02722 A05I-02723 A05I-02724 A05I-02725 A05I-02726 A05I-02727 A05I-02728 A05I-02729 A05I-02730 A05I-02731 A05I-02732 A05I-02733 A05I-02734 A05I-02735 A05I-02736 A05I-02737 A05I-02738 A05I-02739 A05I-02740 A05I-02741 A05I-02742 A05I-02743 A05I-02744 A05I-02745 A05I-02747 A05I-02748 A05I-02749 A05I-02750 A05I-02751 A05I-02752 A05I-02753 A05I-02754 A05I-02755 A05I-02756 A05I-02757 A05I-02758 A05I-02759 A05I-02760 A05I-02761 A05I-02762 A05I-02763 A05I-02764 A05I-02765 A05I-02766 A05I-02767 A05I-02768 A05I-02769 A05I-02770 A05I
Recalling Firm/
Philips Medical Systems
2301 5th Ave Ste 200
Seattle WA 98121
For Additional Information Contact Dennis Daniels
Manufacturer Reason
for Recall
Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.
FDA Determined
Cause 2
Component design/selection
Action Three separate Urgent - Device Recall letter were sent out on April 30, 2008 via tractable letter using UPS. 1) The end-customer letter advises of the recall, contact information to arrange a replacement of the device and instructions for checking the equipment to insure it is working correctly. "If your HeartStart Home Defibrillator is one of the affected devices or if you have any questions about this recall, please contact Philips Healthcare at 1.800.263.3342, option 5, or visit www.HeartStartHome.com to arrange for a free replacement defibrillator. If you have given your HeartStart to someone else as a gift, please call us promptly and let us know how to contact that person to arrange for the replacement. While waiting for your replacement unit, Philips recommends that you perform a battery insertion test (BLT) of your HeartStart, as described in the Owner's Manual provided with it. Simply remove the battery, wait 5 seconds, reinstall the battery, then press the shock button when directed. After the BIT has finished, press the green On/Off button twice. If either button does not seem to work, please contact Philips immediate." 2) The dealer/distributor and retail letters advises of the recall; request that the dealer/distributor provide end-customer information. "As part of a coordinated effort involving notification of regulatory authorities, other Philips entities, and support personnel, Philips will be contacting all affected customers directly. It is not necessary for you or your sub-distributors to contact customers." 3) The international customer contacts will be made via established Philips sales and distribution channels. Philips will be replacing international units under a Field Change Order Process (to be provided by the firm). In addition, Philips will provide a website that will provide customers with information related to the recall (www.HeartStartHome).
Quantity in Commerce 3,959 units
Distribution Worldwide including USA and countries of Austria, Australia, Canada, Colombia, German, Denmark, Dominican Republic, Spain, France, England, Ireland, Italy, Japan, Netherlands, Norway, New Zealand, Panama, Sweden, Singapore, and South Africa.
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 = PHILIPS MEDICAL SYSTEMS