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U.S. Department of Health and Human Services

Class 2 Device Recall Oarm 1000 Imaging System

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  Class 2 Device Recall Oarm 1000 Imaging System see related information
Date Initiated by Firm January 25, 2018
Create Date March 08, 2018
Recall Status1 Terminated 3 on April 01, 2019
Recall Number Z-0928-2018
Recall Event ID 79275
510(K)Number K092564  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4) Model: BASE OARM Bl70000028230 SYS 230V, Product Number: Bl70000028230 (UDI: 00643169353992); (5) BASE OARM Bl70000028230R SYS 230V RWK, Product Number: Bl70000028230R (UDI: 00643169354081)

Product Usage:
The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Code Information Serial Numbers: B14070845 B13050682 B13080716 B14010771 B14010779 B14020790 B14040813 B15020929 B14020789 B15101034 B15101041 B16011100 B16021102 B15060987 B14110904 B16021105 B16021106 B15020941 B15050972 B15030949 B16021111 B15091028 B14010774 B14030797 B16021112 B16031114 B16041137 B16061190 B15010926 B15060988 B16061196 B13080721 B16071207 B16071213 B13080722 B16071215 B16081234 B17101333 B14030803 B14040814 B17101445 B14040817 B17071466 B17121536 B14050830 B17121544 B14050829 B14070857 B14080865 B14090881 B13080718 B14050824 B14060833 B13060683 B13060698 B15030948 B15050971 B14010781 B14030802 B14030805 B15121072 B16011082 B13090723 B13120770 B14010772 B13120764 B14010776 B14030785 B14110898 B14120906 B14030807 B14050823 B14060832 B14060834 B16111259 B15020925 B15091014R B17031257 B13080717 B14010775R B15091020 B14040811 B14050822 B14070840 B15030946 B14030808 B13080724 B14070851 B14020773 B14120905 B14020794 B14080860 B15010922 B15020943 B15030951 B15060976 B15060984 B15070999 B15091023 B15091032 B14110897R B14040810 O-Arm 831 O-arm 842 B14070854 B14090883 B14120909 B15010921 B15030954 B15091024 B15030952 B14080871 B14090872 B14090880 B14120908 B14120913 B15020928 B15030953 B15071004 B15091026 B15101039 B14080859 B15081008 B15091030 B15121049 B16011095 B14090873 B15111055 B15121064 B14080869 B14020786 B14070852 B14100887 B14110903 B14120917 B15010920 B15020927 B15020940 B14020792 B14100891 B14100893 B14120910 B15091018 B14020788 B14060836 B15040961 B16031115 B14040819 B14110899 B15040960 B15091019 B14090885 B15020942 B14050827 B14080867 B14070835 B15030955 B15040959 B14090882 B13120765 B14070846 B16051155 B14120915 B15071000 B14010777 B14090884 B14100886 B14100894 B14110902 B15050975 B16041138 B14110896 B15030950 B14010769 B14090863 B15121058 B13080720 O-arm 804 B14070839 B15020937 B15040958 B15091017 B14110901 B13120766 B14080862 B14080864 B14100895 B14120907 B14120912 B15010919 B15020939 B13120763 B13120768 B14020795 B14050826 B14070847 B14070849 B14080861 B14080866 B14100888 B15030947 B15060980 B15070992 B15081005 B15091012 B16031120 B16041136 B13090729 B14100889 B14100890 B17011287 B14120916 B13080715 B16081226 B16101239 B14010780 B16051159 B15030945 B14030796 B14040816 B14050821 B13050681 B13050685 B14030799 B15020938 B16041150 B14030800 B14090874 B14120911 B14030801 B14120918 B16031126 B15010923 B16061164 B14030787 B15050968 B14020793 B14030798 B14060838 B13080711 B13080719 B14030806 B15071003 B14050815 B15010924 B13070710 B14010782 B14020784 B14070843 B14010778 B14040812 B14040820 B14050828 
Recalling Firm/
Medtronic Navigation, Inc.-Littleton
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact Dean Honkonen
Manufacturer Reason
for Recall
Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.
FDA Determined
Cause 2
Software design
Action Medtronic sent an Urgent Medical Device Correction letter to their customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a local service representative will contact you to install the update. For questions contact Medtronic Technical Support at 1-800-595-9709.
Quantity in Commerce 253
Distribution Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Puerto Rico. Distributed in Algeria, Australia, Chile, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Jordan, Lebanon, Sri Lanka, New Zealand, Nicaragua, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.
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 = OXO and Original Applicant = MEDTRONIC NAVIGATION, INC. (LITTLETON)