| Class 2 Device Recall V Series Monitor | |
Date Initiated by Firm | October 14, 2011 |
Date Posted | February 24, 2012 |
Recall Status1 |
Terminated 3 on June 11, 2013 |
Recall Number | Z-1102-2012 |
Recall Event ID |
60976 |
Product Classification |
Monitor, cardiac (incl. Cardiotachometer & rate alarm) - Product Code DRT
|
Product | V Series Monitor
Mindray DS USA, Inc.
800 MacArthur Boulevard.
Mahwah, NJ 07430
The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices |
Code Information |
510 K - K102004 P/N and Serial Numbers 0998-00-1800-101 EGK16006559 0998-00-1800-101 EGK16006562 0998-00-1800-101 EGK16006590 0998-00-1800-101 EGK16006601 0998-00-1800-101 EGK16006628 0998-00-1800-101 EGK16006633 0998-00-1800-101 EGK17006943 0998-00-1800-101 EGK13004267 0998-00-1800-101 EGK13004271 0998-00-1800-101 EGK13004302 0998-00-1800-101 EGK13004303 0998-00-1800-101 EGK13004307 0998-00-1800-101 EGK14005442 0998-00-1800-101 EGK14005446 0998-00-1800-101 EGK14005447 0998-00-1800-101 EGK14005450 0998-00-1800-101 EGK14005454 0998-00-1800-101 EGK14005455 0998-00-1800-101 EGK14005462 0998-00-1800-101 EGK14005480 0998-00-1800-101 EGK14005485 0998-00-1800-101 EGK14005503 0998-00-1800-101 EGK15006285 0998-00-1800-101 EGK15006288 0998-00-1800-101 EGK15006297 0998-00-1800-101 EGK15006299 0998-00-1800-101 EGK15006302 0998-00-1800-201 EGN14005560 0998-00-1800-201 EGN14005889 0998-00-1800-101 EG-08000821 0998-00-1800-101 EG-09001590 0998-00-1800-101 EG-09001600 0998-00-1800-101 EG-09001610 0998-00-1800-101 EG-09001612 0998-00-1800-101 EG-09001617 0998-00-1800-101 EG-09001621 0998-00-1800-101 EG-0B002492 0998-00-1800-101 EGK11002620 0998-00-1800-101 EGK12002944 0998-00-1800-101 EGK12002945 0998-00-1800-101 EGK12002967 0998-00-1800-101 EGK12002990 0998-00-1800-101 EGK12002992 0998-00-1800-101 EGK13003806 0998-00-1800-101 EGK13003825 0998-00-1800-101 EGK13003834 0998-00-1800-101 EGK13003854 0998-00-1800-101 EGK13004293 0998-00-1800-101 EGK14005464 0998-00-1800-101 EGK14005909 0998-00-1800-101 EGK14005917 0998-00-1800-101 EGK14005919 0998-00-1800-201 EGN12002923 0998-00-1800-201 EGN12002927 0998-00-1800-201 EGN13003759 0998-00-1800-201 EGN13003764 0998-00-1800-201 EGN13003768 0998-00-1800-201 EGN13003791 0998-00-1800-201 EGN13003795 0998-00-1800-201 EGN13003797 0998-00-1800-201 EGN14005529 0998-00-1800-101 EGK13004251 0998-00-1800-101 EGK13004259 0998-00-1800-101 EGK13004263 0998-00-1800-101 EGK13004280 0998-00-1800-101 EGK13004285 0998-00-1800-101 EGK14005436 0998-00-1800-101 EGK14005437 0998-00-1800-101 EGK14005484 0998-00-1800-101 EGK14005912 0998-00-1800-101 EGK15006292 0998-00-1800-101 EGK15006295 0998-00-1800-101 EGK15006303 0998-00-1800-101 EGK17007607 0998-00-1800-201 EGN14005522 0998-00-1800-201 EGN11002574 0998-00-1800-201 EGN11002578 0998-00-1800-201 EGN11002584 0998-00-1800-201 EGN11002588 0998-00-1800-201 EGN13004514 0998-00-1800-201 EGN13004518 0998-00-1800-201 EGN13004532 0998-00-1800-201 EGN13004544 0998-00-1800-201 EGN13004560 0998-00-1800-201 EGN14005514 0998-00-1800-201 EGN14005518 0998-00-1800-201 EGN14005530 0998-00-1800-201 EGN14005555 0998-00-1800-201 EGN14005895 0998-00-1800-201 EGN13004537 0998-00-1800-201 EGN13004561 0998-00-1800-201 EGN14005875 0998-00-1800-201 EGN14005877 0998-00-1800-201 EGN14005878 0998-00-1800-201 EGN14005897 0998-00-1800-101 EG-08000768 0998-00-1800-101 EG-08000769 0998-00-1800-101 EG-08000771 0998-00-1800-101 EG-08000774 0998-00-1800-101 EG-08000775 0998-00-1800-101 EG-08000776 0998-00-1800-101 EG-08000779 0998-00-1800-101 EG-08000780 0998-00-1800-101 EG-08000783 0998-00-1800-101 EG-08000785 0998-00-1800-101 EG-08000787 0998-00-1800-101 EG-08000788 0998-00-1800-101 EG-08000789 0998-00-1800-101 EG-08000790 0998-00-1800-101 EG-08000791 0998-00-1800-101 EG-08000792 0998-00-1800-101 EG-08000793 0998-00-1800-101 EG-08000794 0998-00-1800-101 EG-08000795 0998-00-1800-101 EG-08000796 0998-00-1800-101 EG-08000797 0998-00-1800-101 EG-08000801 0998-00-1800-101 EG-08000802 0998-00-1800-101 EG-08000804 0998-00-1800-101 EG-08000805 0998-00-1800-101 EG-08000807 0998-00-1800-101 EG-08000808 0998-00-1800-101 EG-08000809 0998-00-1800-101 EG-08000810 0998-00-1800-101 EG-08000814 0998-00-1800-101 EG-08000815 0998-00-1800-101 EG-08000818 0998-00-1800-101 EG-08000819 0998-00-1800-101 EG-08000820 0998-00-1800-101 EG-08000822 0998-00-1800-101 EG-08000824 0998-00-1800-101 EG-09001572 0998-00-1800-101 EG-09001573 0998-00-1800-101 EG-09001574 0998-00-1800-101 EG-09001575 0998-00-1800-101 EG-09001576 0998-00-1800-101 EG-09001577 0998-00-1800-101 EG-09001578 0998-00-1800-101 EG-09001580 0998-00-1800-101 EG-09001581 0998-00-1800-101 EG-09001582 0998-00-1800-101 EG-09001583 0998-00-1800-101 EG-09001584 0998-00-1800-101 EG-09001585 0998-00-1800-101 EG-09001586 0998-00-1800-101 EG-09001587 0998-00-1800-101 EG-09001588 0998-00-1800-101 EG-09001589 0998-00-1800-101 EG-09001591 0998-00-1800-101 EG-09001592 0998-00-1800-101 EG-09001593 0998-00-1800-101 EG-09001594 0998-00-1800-101 EG-09001595 0998-00-1800-101 EG-09001597 0998-00-1800-101 EG-09001598 0998-00-1800-101 EG-09001599 0998-00-1800-101 EG-09001602 0998-00-1800-101 EG-09001603 0998-00-1800-101 EG-09001605 0998-00-1800-101 EG-09001606 0998-00-1800-101 EG-09001607 0998-00-1800-101 EG-09001608 0998-00-1800-101 EG-09001609 0998-00-1800-101 EG-09001611 0998-00-1800-101 EG-09001613 0998-00-1800-101 EG-09001614 0998-00-1800-101 EG-09001615 0998-00-1800-101 EG-09001618 0998-00-1800-101 EG-09001620 0998-00-1800-101 EG-09001622 0998-00-1800-101 EG-09001623 0998-00-1800-101 EG-09001624 0998-00-1800-101 EG-09001626 0998-00-1800-101 EG-09001627 0998-00-1800-101 EG-0B002485 0998-00-1800-101 EG-0B002487 0998-00-1800-101 EG-0B002488 0998-00-1800-101 EG-0B002489 0998-00-1800-101 EG-0B002493 0998-00-1800-101 EG-0B002494 0998-00-1800-101 EG-0B002496 0998-00-1800-101 EG-0B002497 0998-00-1800-101 EG-0B002501 0998-00-1800-101 EGK0C002568 0998-00-1800-101 EGK11002608 0998-00-1800-101 EGK11002610 0998-00-1800-101 EGK11002611 0998-00-1800-101 EGK11002614 0998-00-1800-101 EGK11002616 0998-00-1800-101 EGK11002624 0998-00-1800-101 EGK11002629 0998-00-1800-101 EGK11002631 0998-00-1800-101 EGK11002632 0998-00-1800-101 EGK11002633 0998-00-1800-101 EGK12002941 0998-00-1800-101 EGK12002942 0998-00-1800-101 EGK12002943 0998-00-1800-101 EGK12002946 0998-00-1800-101 EGK12002947 0998-00-1800-101 EGK12002948 0998-00-1800-101 EGK12002949 0998-00-1800-101 EGK12002950 0998-00-1800-101 EGK12002952 0998-00-1800-101 EGK12002953 0998-00-1800-101 EGK12002954 0998-00-1800-101 EGK12002955 0998-00-1800-101 EGK12002956 0998-00-1800-101 EGK12002957 0998-00-1800-101 EGK12002958 0998-00-1800-101 EGK12002959 0998-00-1800-101 EGK12002960 0998-00-1800-101 EGK12002961 0998-00-1800-101 EGK12002962 0998-00-1800-101 EGK12002963 0998-00-1800-101 EGK12002964 0998-00-1800-101 EGK12002965 0998-00-1800-101 EGK12002966 0998-00-1800-101 EGK12002968 0998-00-1800-101 EGK12002969 0998-00-1800-101 EGK12002970 0998-00-1800-101 EGK12002971 0998-00-1800-101 EGK12002972 0998-00-1800-101 EGK12002973 0998-00-1800-101 EGK12002974 0998-00-1800-101 EGK12002975 0998-00-1800-101 EGK12002976 0998-00-1800-101 EGK12002977 0998-00-1800-101 EGK12002978 0998-00-1800-101 EGK12002979 0998-00-1800-101 EGK12002980 0998-00-1800-101 EGK12002981 0998-00-1800-101 EGK12002982 0998-00-1800-101 EGK12002983 0998-00-1800-101 EGK12002984 0998-00-1800-101 EGK12002985 0998-00-1800-101 EGK12002986 0998-00-1800-101 EGK12002987 0998-00-1800-101 EGK12002988 0998-00-1800-101 EGK12002989 0998-00-1800-101 EGK12002991 0998-00-1800-101 EGK12002993 0998-00-1800-101 EGK13003807 0998-00-1800-101 EGK13003808 0998-00-1800-101 EGK13003809 0998-00-1800-101 EGK13003810 0998-00-1800-101 EGK13003811 0998-00-1800-101 EGK13003812 0998-00-1800-101 EGK13003813 0998-00-1800-101 EGK13003814 0998-00-1800-101 EGK13003815 0998-00-1800-101 EGK13003816 0998-00-1800-101 EGK13003817 0998-00-1800-101 EGK13003818 0998-00-1800-101 EGK13003819 0998-00-1800-101 EGK13003820 0998-00-1800-101 EGK13003821 0998-00-1800-101 EGK13003822 0998-00-1800-101 EGK13003823 0998-00-1800-101 EGK13003826 0998-00-1800-101 EGK13003827 0998-00-1800-101 EGK13003828 0998-00-1800-101 EGK13003829 0998-00-1800-101 EGK13003830 0998-00-1800-101 EGK13003831 0998-00-1800-101 EGK13003832 0998-00-1800-101 EGK13003833 0998-00-1800-101 EGK13003835 0998-00-1800-101 EGK13003836 0998-00-1800-101 EGK13003837 0998-00-1800-101 EGK13003838 0998-00-1800-101 EGK13003839 0998-00-1800-101 EGK13003840 0998-00-1800-101 EGK13003841 0998-00-1800-101 EGK13003842 0998-00-1800-101 EGK13003843 0998-00-1800-101 EGK13003844 0998-00-1800-101 EGK13003845 0998-00-1800-101 EGK13003846 0998-00-1800-101 EGK13003847 0998-00-1800-101 EGK13003848 0998-00-1800-101 EGK13003849 0998-00-1800-101 EGK13003851 0998-00-1800-101 EGK13003852 0998-00-1800-101 EGK13003853 0998-00-1800-101 EGK13003855 0998-00-1800-101 EGK13003856 0998-00-1800-101 EGK13003857 0998-00-1800-201 EG-08000729 0998-00-1800-201 EG-08000733 0998-00-1800-201 EG-08000737 0998-00-1800-201 EG-08000738 0998-00-1800-201 EG-08000746 0998-00-1800-201 EG-08000748 0998-00-1800-201 EG-08000750 0998-00-1800-201 EG-08000753 0998-00-1800-201 EG-08000759 0998-00-1800-201 EG-08000760 0998-00-1800-201 EG-08000764 0998-00-1800-201 EG-08000765 0998-00-1800-201 EG-09001826 0998-00-1800-201 EG-09001828 0998-00-1800-201 EG-09001831 0998-00-1800-201 EG-09001832 0998-00-1800-201 EG-09001834 0998-00-1800-201 EG-09001836 0998-00-1800-201 EG-09001840 0998-00-1800-201 EG-09001844 0998-00-1800-201 EG-09001845 0998-00-1800-201 EG-09001846 0998-00-1800-201 EG-09001847 0998-00-1800-201 EG-09001848 0998-00-1800-201 EG-09001852 0998-00-1800-201 EGN11002570 0998-00-1800-201 EGN11002571 0998-00-1800-201 EGN11002573 0998-00-1800-201 EGN11002576 0998-00-1800-201 EGN11002577 0998-00-1800-201 EGN11002579 0998-00-1800-201 EGN11002581 0998-00-1800-201 EGN11002582 0998-00-1800-201 EGN11002585 0998-00-1800-201 EGN11002586 0998-00-1800-201 EGN11002591 0998-00-1800-201 EGN11002593 0998-00-1800-201 EGN11002595 0998-00-1800-201 EGN11002597 0998-00-1800-201 EGN11002598 0998-00-1800-201 EGN12002884 0998-00-1800-201 EGN12002885 0998-00-1800-201 EGN12002886 0998-00-1800-201 EGN12002887 0998-00-1800-201 EGN12002888 0998-00-1800-201 EGN12002889 0998-00-1800-201 EGN12002890 0998-00-1800-201 EGN12002891 0998-00-1800-201 EGN12002892 0998-00-1800-201 EGN12002893 0998-00-1800-201 EGN12002894 0998-00-1800-201 EGN12002896 0998-00-1800-201 EGN12002899 0998-00-1800-201 EGN12002900 0998-00-1800-201 EGN12002901 0998-00-1800-201 EGN12002902 0998-00-1800-201 EGN12002903 0998-00-1800-201 EGN12002904 0998-00-1800-201 EGN12002906 0998-00-1800-201 EGN12002907 0998-00-1800-201 EGN12002908 0998-00-1800-201 EGN12002909 0998-00-1800-201 EGN12002910 0998-00-1800-201 EGN12002912 0998-00-1800-201 EGN12002914 0998-00-1800-201 EGN12002916 0998-00-1800-201 EGN12002917 0998-00-1800-201 EGN12002918 0998-00-1800-201 EGN12002920 0998-00-1800-201 EGN12002921 0998-00-1800-201 EGN12002922 0998-00-1800-201 EGN12002924 0998-00-1800-201 EGN12002925 0998-00-1800-201 EGN12002926 0998-00-1800-201 EGN12002928 0998-00-1800-201 EGN12002929 0998-00-1800-201 EGN12002930 0998-00-1800-201 EGN12002931 0998-00-1800-201 EGN12002932 0998-00-1800-201 EGN12002933 0998-00-1800-201 EGN12002934 0998-00-1800-201 EGN12002936 0998-00-1800-201 EGN12002938 0998-00-1800-201 EGN12002940 0998-00-1800-201 EGN13003760 0998-00-1800-201 EGN13003761 0998-00-1800-201 EGN13003762 0998-00-1800-201 EGN13003765 0998-00-1800-201 EGN13003767 0998-00-1800-201 EGN13003769 0998-00-1800-201 EGN13003770 0998-00-1800-201 EGN13003771 0998-00-1800-201 EGN13003772 0998-00-1800-201 EGN13003773 0998-00-1800-201 EGN13003774 0998-00-1800-201 EGN13003775 0998-00-1800-201 EGN13003776 0998-00-1800-201 EGN13003778 0998-00-1800-201 EGN13003779 0998-00-1800-201 EGN13003780 0998-00-1800-201 EGN13003781 0998-00-1800-201 EGN13003782 0998-00-1800-201 EGN13003783 0998-00-1800-201 EGN13003784 0998-00-1800-201 EGN13003785 0998-00-1800-201 EGN13003786 0998-00-1800-201 EGN13003788 0998-00-1800-201 EGN13003789 0998-00-1800-201 EGN13003790 0998-00-1800-201 EGN13003792 0998-00-1800-201 EGN13003793 0998-00-1800-201 EGN13003794 0998-00-1800-201 EGN13003796 0998-00-1800-201 EGN13003798 0998-00-1800-201 EGN13003799 0998-00-1800-201 EGN13003800 0998-00-1800-201 EGN13003801 0998-00-1800-201 EGN13003803 0998-00-1800-201 EGN13003805 0998-00-1800-201 EGN13003755 0998-00-1800-201 EGN13004513 0998-00-1800-201 EGN13004516 0998-00-1800-201 EGN13004519 0998-00-1800-201 EGN13004520 0998-00-1800-201 EGN13004525 0998-00-1800-201 EGN13004531 0998-00-1800-201 EGN13004534 0998-00-1800-201 EGN13004549 0998-00-1800-201 EGN13004558 0998-00-1800-201 EGN14005512 0998-00-1800-201 EGN14005516 0998-00-1800-201 EGN14005520 0998-00-1800-201 EGN14005523 0998-00-1800-201 EGN14005528 0998-00-1800-201 EGN14005532 0998-00-1800-201 EGN14005551 0998-00-1800-201 EGN14005554 0998-00-1800-201 EGN14005558 0998-00-1800-201 EGN14005562 0998-00-1800-201 EGN14005874 0998-00-1800-201 EGN14005882 0998-00-1800-201 EGN14005888 0998-00-1800-201 EGN14005890 0998-00-1800-101 EG-08000767 0998-00-1800-101 EGK14005491 0998-00-1800-101 EGK13004289 0998-00-1800-101 EGK14005434 0998-00-1800-101 EGK14005479 0998-00-1800-201 EG-08000740 0998-00-1800-201 EG-08000766 0998-00-1800-201 EG-09001825 0998-00-1800-201 EG-09001830 0998-00-1800-201 EG-09001838 0998-00-1800-201 EG-09001839 0998-00-1800-201 EG-09001843 0998-00-1800-201 EG-09001849 0998-00-1800-201 EGN13003756 0998-00-1800-201 EGN13003763 0998-00-1800-201 EGN13003802 0998-00-1800-201 EGN13004557 0998-00-1800-201 EGN14005513 0998-00-1800-201 EGN14005525 0998-00-1800-201 EGN14005543 0998-00-1800-201 EGN14005891 0998-00-1800-101 EGK14005490 0998-00-1800-201 EGN14005540 0998-00-1800-101 EGK13004250 0998-00-1800-101 EGK13004252 0998-00-1800-101 EGK13004258 0998-00-1800-101 EGK13004261 0998-00-1800-101 EGK13004262 0998-00-1800-101 EGK13004264 0998-00-1800-101 EGK13004270 0998-00-1800-101 EGK13004272 0998-00-1800-101 EGK13004276 0998-00-1800-101 EGK13004278 0998-00-1800-101 EGK13004282 0998-00-1800-101 EGK13004283 0998-00-1800-101 EGK13004286 0998-00-1800-101 EGK13004287 0998-00-1800-101 EGK13004294 0998-00-1800-101 EGK13004296 0998-00-1800-101 EGK13004298 0998-00-1800-101 EGK13004299 0998-00-1800-101 EGK13004301 0998-00-1800-101 EGK14005453 0998-00-1800-101 EGK14005457 0998-00-1800-101 EGK14005458 0998-00-1800-101 EGK14005459 0998-00-1800-101 EGK14005463 0998-00-1800-101 EGK14005467 0998-00-1800-101 EGK14005472 0998-00-1800-101 EGK14005482 0998-00-1800-101 EGK14005486 0998-00-1800-101 EGK14005488 0998-00-1800-101 EGK14005496 0998-00-1800-101 EGK14005899 0998-00-1800-101 EGK14005903 0998-00-1800-101 EGK14005907 0998-00-1800-101 EGK15006284 0998-00-1800-101 EGK15006286 0998-00-1800-101 EGK15006287 0998-00-1800-101 EGK15006289 0998-00-1800-101 EGK15006291 0998-00-1800-101 EGK15006293 0998-00-1800-101 EGK15006294 0998-00-1800-101 EGK15006300 0998-00-1800-101 EGK15006301 0998-00-1800-201 EG-08000742 0998-00-1800-201 EG-09001827 0998-00-1800-201 EG-09001851 0998-00-1800-201 EG-09001853 0998-00-1800-201 EGN12002905 0998-00-1800-201 EGN13003752 0998-00-1800-201 EGN13003753 0998-00-1800-201 EGN13003757 0998-00-1800-201 EGN13003758 0998-00-1800-201 EGN13003777 0998-00-1800-201 EGN13003787 0998-00-1800-201 EGN13004517 0998-00-1800-201 EGN13004538 0998-00-1800-201 EGN13004554 0998-00-1800-201 EGN13004555 0998-00-1800-201 EGN13004556 0998-00-1800-201 EGN14005508 0998-00-1800-201 EGN14005521 0998-00-1800-201 EGN14005524 0998-00-1800-201 EGN14005548 0998-00-1800-201 EGN14005552 0998-00-1800-201 EGN14005556 0998-00-1800-201 EGN14005559 0998-00-1800-201 EGN14005561 0998-00-1800-201 EGN14005871 0998-00-1800-201 EGN14005872 0998-00-1800-201 EGN14005879 0998-00-1800-201 EGN14005880 0998-00-1800-201 EGN14005881 0998-00-1800-201 EGN14005886 0998-00-1800-201 EGN14005887 0998-00-1800-201 EGN14005894 0998-00-1800-201 EGN14005898 0998-00-1800-101 EGK14005435 0998-00-1800-101 EGK14005451 0998-00-1800-101 EGK14005456 0998-00-1800-101 EGK14005468 0998-00-1800-101 EGK14005470 0998-00-1800-101 EGK14005494 0998-00-1800-101 EGK14005495 0998-00-1800-101 EGK14005500 0998-00-1800-101 EGK14005505 0998-00-1800-101 EGK14005905 0998-00-1800-201 EGN13004515 0998-00-1800-201 EGN14005535 0998-00-1800-201 EGN14005539 0998-00-1800-201 EGN14005883 |
Recalling Firm/ Manufacturer |
Mindray DS USA, Inc. d.b.a. Mindray North America 800 MacArthur Blvd. Mahwah NJ 07430
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For Additional Information Contact | Ms. Diane Arpino 201-995-8407 |
Manufacturer Reason for Recall | A system database corruption may occur that causes the V Series Monitor to reset. |
FDA Determined Cause 2 | Process control |
Action | The firm, Mindray, sent an "URGENT PRODUCT CORRECTIVE ACTION" letter dated October 14, 2011 on October 17, 2011 via certified mail, return receipt requested, signature required to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact their Mindray Service Representative at 1-800-288-2121, to arrange for software upgrade of the V Series Monitor(s) in their facility.
If you have any questions, contact Manager, Regulatory Affairs and Clinical Affairs at 201-995-8407 or email: d.arpino@mindray.com. |
Quantity in Commerce | 542 units US ; 153 units International |
Distribution | Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, IN, MO, NE, PR, and SD; and countries of: Australia, Chile, Columbia, United Kingdom, and Venezula. |
Total Product Life Cycle | TPLC Device Report |
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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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