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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart XL

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 Class 2 Recall
HeartStart XL
see related information
Date Posted October 25, 2007
Recall Status1 Open
Recall Number Z-0062-2008
Recall Event ID 44751
Premarket Notification
510(K) Number
K021453 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product HeartStart XL Defibrillator/Monitor, Model: M4735A
Code Information S/N's: Lot numbers(s) or serial number(s) US00453446 US00453452 US00453458 US00453459 US00453460 US00453461 US00453463 US00453465 US00453466 US00453471 US00453472 US00453475 US00453477 US00453479 US00453486 US00453487 US00453488 US00453489 US00453490 US00453491 US00453492 US00453513 US00453514 US00453515 US00453516 US00453517 US00453541 US00453542 US00453543 US00453544 US00453545 US00453546 US00453547 US00453548 US00453549 US00453550 US00453552 US00453553 US00453564 US00453565 US00453566 US00453596 US00453597 US00453598 US00453599 US00453601 US00453602 US00453603 US00453604 US00453607 US00453609 US00453610 US00453611 US00453613 US00453614 US00453615 US00453616 US00453617 US00453618 US00453619 US00453621 US00453622 US00453623 US00453624 US00453631 US00453634 US00453635 US00453636 US00453637 US00453638 US00453640 US00453641 US00453642 US00453645 US00453646 US00453647 US00453648 US00453649 US00453650 US00453651 US00453652 US00453653 US00453654 US00453655 US00453656 US00453657 US00453658 US00453659 US00453660 US00453661 US00453662 US00453663 US00453664 US00453666 US00453667 US00453668 US00453669 US00453670 US00453671 US00453672 US00453673 US00453674 US00453675 US00453676 US00453677 US00453678 US00453679 US00453691 US00453692 US00453693 US00453694 US00453695 US00453696 US00453712 US00453714 US00453715 US00453716 US00453717 US00453721 US00453723 US00453724 US00453725 US00453726 US00453730 US00453731 US00453732 US00453733 US00453734 US00453735 US00453736 US00453737 US00453738 US00453739 US00453740 US00453742 US00453744 US00453745 US00453746 US00453747 US00453748 US00453749 US00453751 US00453752 US00453753 US00453754 US00453755 US00453758 US00453759 US00453760 US00453766 US00453767 US00453796 US00453797 US00453798 US00453799 US00453800 US00453801 US00453802 US00453803 US00453804 US00453805 US00453806 US00453807 US00453808 US00453809 US00453810 US00453811 US00453812 US00453813 US00453814 US00453815 US00453816 US00453817 US00453818 US00453819 US00453820 US00453821 US00453822 US00453823 US00453824 US00453825 US00453826 US00453827 US00453828 US00453829 US00453830 US00453831 US00453832 US00453833 US00453834 US00453835 US00453836 US00453847 US00453849 US00453850 US00453852 US00453853 US00453854 US00453855 US00453856 US00453857 US00453861 US00453863 US00453864 US00453865 US00453866 US00453867 US00453868 US00453869 US00453870 US00453871 US00453872 US00453873 US00453874 US00453907 US00453908 US00453909 US00453910
Recalling Firm/
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Philips Medical notified accounts (Distributors/Healthcare Customers) by letter dated 9/4/07. Users are requested if possible to remove the unit from service. Firm will have Field representative conduct correction.
Quantity in Commerce 147 boards
Distribution Puerto Rico, Canada, Argentina, Australia, Brazil, China, Domincan Republic, Czech Republic, Hong Kong, India, Japan, Korea, Macau, Singapore, Spain, South Africa, Slovenia, Sweden, Switzerland, Ireland, UK, France, Kuwait, Poland, and Germany
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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