Events

Recall of Hologic Discovery

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51692
  • Event Risk Class
    Class 2
  • Event Number
    Z-1725-2009
  • Event Initiated Date
    2009-04-07
  • Event Date Posted
    2009-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80996
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bone Densitometer - Product Code KGI
  • Reason
    System may not turn off at the end of the x-ray and cause additional x-ray exposure.
  • Action
    Hologic issued an Urgent: Medical Device Recall customer notification letter, dated April 17, 2009, by certified mail to inform customers of the problem. With the notification letter, customers will receive the following: -Software version Apex 12.6.2, 2.3.2, or 2.4.2 -Instructions to upgrade their systems with the provided software and to verify the new version on the system as a confirmation that the software was successfully loaded. -New Operator's Manual for installations where the operating characteristics of the system have changed due to the software upgrade. For Customers with systems with software versions other than 12.6, 2.3, or 2.4: Customers were asked to upgrade their QDR software, return their old QDR software disk, and complete and return to Hologic the enclosed Confirmation of Notification.

Device

Hologic Discovery
  • Model / Serial
    S/N: 80348 80652 81530 82238 82256 82386 82437 82620 82632 82708 82793 82794 82796 82798 82799 82806 82808 82810 82811 82812 82813 82814 82815 82818 82824 82825 82826 82827 82828 82832 82833 82834 82835 82836 82837 82838 82839 82840 82842 82843 82844 82845 82846 82847 82851 82853 82854 82855 82856 82857 82859 82860 82862 82865 82866 82867 82872 82875 82876 82877 82879 82880 82881 82883 82887 82889 82891 82892 82895 82896 82897 82898 82900 82901 82902 82903 82904 82906 82909 82910 82911 82912 82916 82917 82918 82920 82921 82922 82924 82926 82927 82928 82929 82932 82933 82935 82936 82939 82941 82944 82945 82947 82949 82950 82956 82957 82958 82959 82960 82963 82964 82967 82968 82969 82970 82972 82976 82977 82978 82979 82981 82982 82983 82986 82988 82989 82990 82991 82992 82993 82996 83000 83001 83002 83003 83004 83005 83007 83008 83009 83010 83011 83013 83014 83015 83017 83018 83019 83020 83021 83022 83023 83025 83027 83028 83029 83032 83034 83035 83038 83039 83040 83041 83043 83044 83045 83046 83047 83049 83050 83051 83055 83057 83059 83062 83064 83065 83072 83074 83075 83076 83077 83080 83081 83082 83083 83084 83085 83086 83087 83088 83090 83091 83092 83093 83094 83096 83098 83100 83105 83107 83109 83111 83112 83114 83115 83116 83118 83120 83121 83122 83126 83131 83133 83134 83139 83141 83142 83144 83148 83149 83150 83154 83155 83156 83157 83159 83160 83161 83163 83164 83165 83169 83170 83171 83173 83174 83175 83176 83177 83178 83181 83182 83185 83186 83190 83191 83194 83195 83197 83199 83199 83201 83202 83203 83205 83206 83207 83209 83210 83211 83213 83216 83218 83219 83220 83221 83223 83225 83227 83229 83231 83233 83235 83240 83241 83243 83245 83246 83249 83252 83254 83255 83256 83260 83261 83263 83264 83267 83268 83269 83271 83272 83273 83276 83277 83279 83280 83281 83282 83285 83287 83290 83291 83292 83293 83294 83300 83301 83302 83305 83306 83308 83309 83310 83311 83312 83313 83314 83316 83317 83321 83322 83323 83324 83326 83328 83329 83332 83334 83337 83338 83342 83343 83346 83348 83350 83351 83352 83353 83356 83357 83360 83362 83363 83365 83366 83367 83369 83370 83371 83373 83376 83377 83378 83384 83385 83386 83387 83388 83390 83395 83397 83398 83399 83400 83402 83406 83411 83412 83413 83414 83415 83417 83418 83419 83420 83421 83422 83425 83426 83427 83428 83429 83430 83431 83432 83435 83436 83438 83439 83440 83441 83442 83445 83447 83448 83450 83451 83452 83454 83455 83456 83457 83458 83459 83460 83464 83467 83468 83469 83470 83472 83474 83475 83478 83480 83483 83484 83485 83489 83491 83492 83493 83494 83495 83496 83497 83499 83500 83502 83503 83506 83509 83510 83511 83512 83514 83515 83516 83517 83519 83520 83521 83522 83523 83524 83525 83526 83527 83529 83530 83531 83532 83534 83535 83536 83537 83538 83541 83542 83543 83544 83545 83547 83548 83549 83550 83555 83556 83557 83558 83560 83561 83562 83563 83566 83568 83569 83574 83575 83577 83578 83579 83580 83581 83583 83584 83585 83586 83590 83591 83596 83597 83598 83599 83600 83602 83603 83606 83607 83608 83609 83616 83617 83618 83619 83620 83622 83626 83627 83628 83629 83631 83632 83633 83634 83635 83637 83639 83640 83642 83643 83645 83647 83648 83649 83651 83652 83657 83658 83659 83660 83662 83667 83668 83669 83670 83673 83674 83675 83676 83677 83680 83682 83683 83686 83688 83689 83690 83691 83693 83694 83699 83700 83701 83702 83703 83704 83705 83708 83710 83711 83712 83714 83715 83716 83717 83719 83721 83722 83723 83726 83727 83728 83729 83730 83731 83733 83734 83735 83736 83738 83739 83740 83741 83743 83744 83746 83747 83748 83749 83755 83757 83759 83761 83764 83765 83767 83768 83769 83770 83773 83774 83775 83776 83777 83778 83780 83781 83786 83788 83789 83790 83791 83794 83796 83800 83801 83804 83807 83810 83811 83812 83814 83816 83819 83821 83822 83823 83824 83825 83826 83827 83828 83829 83830 83831 83833 83834 83835 83836 83838 83839 83840 83842 83844 83845 83847 83848 83849 83851 83852 83853 83854 83855 83856 83857 83861 83862 83863 83864 83866 83869 83870 83871 83872 83873 83876 83877 83878 83880 83881 83883 83887 83888 83890 83892 83893 83895 83896 83898 83899 83900 83902 83904 83912 83913 83916 83920 83921 83922 83926 83931 80121C 80158C 80390A 82791 82792 82797 82800 82801 82802 82803 82805 82807 82816 82817 82819 82820 82821 82822 82823 82829 82830 82831 82841 82848 82849 82852 82858 82861 82864 82868 82870 82871 82873 82874 82878 82882 82884 82885 82886 82888 82890 82894 82899 82905 82907 82908 82913 82914 82915 82919 82923 82925 82930 82931 82934 82937 82938 82940 82942 82946 82948 82951 82952 82953 82954 82955 82961 82962 82965 82966 82971 82973 82974 82975 82980 82984 82985 82994 82995 82997 82998 83006 83012 83016 83024 83026 83030 83031 83033 83036 83037 83042 83048 83052 83053 83054 83056 83058 83060 83061 83063 83066 83067 83068 83069 83070 83071 83073 83078 83079 83089 83095 83097 83099 83101 83102 83103 83104 83106 83108 83110 83113 83117 83119 83123 83124 83125 83127 83128 83129 83130 83132 83135 83136 83137 83138 83140 83143 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and  83935.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudia Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam.
  • Product Description
    Hologic Discovery series Bone Densitometer System || Software versions 12.6, 2.3., or 2.4. || Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Manufacturer Address
    Hologic, Inc., 35 Crosby Dr, Bedford MA 01730
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA