Siemens Medical Solutions USA, Inc Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers 61203 61751 61085 61755 61858 61786 61795 61034 61127 61602 61212 61053 61194 61699 61757 61752 61200 61738 61799 61875 61603 61624 61885 61848 61243 61606 61682 61087 61888 61052 61889 61226 61854 61079 61218 61110 61137 61123 61763 61621 61622 61623 61788 61798 61837 61892 61193 61700 61743 61652 61229 61045 61838 61239 61632 61190 61013 61659 61102 61724 61063 61054 61784 61213 61651 61056 61088 61146 61681 61678 61873 61720 61716 61027 61021 61145 61824 61050 61210 61211 61240 61227 61185 61779 61140 61181 61061 61158 61242 61074 61209 61075 61686 61094 61032 61769 61608 61711 61869 61169 61223 61083 61234 61660 61661 61849 61143 61670 61616 61723 61754 61684 61249 61691 61130 61668 61806 61717 61174 61740 61722 61777 61126 61255 61855 61015 61183 61046 61804 61625 61731 61748 61845 61822 61863 61719 61829 61162 61125 61156 61713 61196 61028 61076 61787 61825 61683 61081 61758 61609 61618 61744 61111 61248 61704 61890 61656 61663 61636 61827 61159 61114 61635 61132 61112 61118 61253 61664 61177 61733 61040 61641 61646 61151 61238 61673 61831 61221 61832 61638 61207 61133 61695 61671 61631 61201 61833 61865 61148 61128 61815 61236 61828 61810 61839 61172 61116 61847 61168 61175 61662 61048 61171 61060 61649 61768 61042 61115 61813 61188 61191 61206 61708 61665 61746 61747 61862 61230 61667 61881 61113 61771 61044 61147 61096 61617 61035 61861 61134 61033 61066 61155 61224 61876 61157 61634 61844 61178 61882 61883 61182 61065 61801 61841 61874 61068 61069 61880 61674 61680 61830 61776 61736 61761 61186 61766 61783 61756 61772 61797 61793 61843 61614 61250 61251 61868 61219 61803 61753 61856 61107 61152 61093 61091 61014 61025 61208 61791 61256 61654 61173 61154 61189 61142 61165 61842 61734 61759 61718 61878 61840 61043 61781 61785 61601 61687 61647 61895 61897 61036 61669 61038 61739 61679 61857 61049 61022 61037 61098 61792 61215 61707 61153 61715 61894 61611 61120 61150 61633 61029 61884 61887 61072 61812 61879 61819 61187 61693 61800 61727 61696 61062 61820 61821 61725 61139 61141 61775 61080 61217 61689 61030 61778 61627 61018 61790 61222 61078 61086 61216 61195 61809 61039 61252 61860 61750 61721 61811 61807 61728 61202 61064 61163 61859 61835 61891 61077 61228 61871 61605 61767 61836 61826 61851 61630 61850 61896 61192 61690 61084 61823 61620 61749 61714 61770 61047 61121 61220 61729 61712 61225 61735 61802 61103 61628 61109 61198 61818 61626 61877 61247 61180 61644 61615 61244 61643 61705 61697 61742 61031 61097 61164 61166 61237 61245 61610 61612 61629 61655 61666 61672 61675 61676 61773 61780 61814 61160 61233 61741 61041 61055 61782 61057 61059 61067 61099 61100 61106 61258 61653 61852 61870 61017 61730 61765 61129 61246 61184 61604 61179 61677 61703 61774 61698 61864 61254 61073 61789 61131 61205 61872 61119 61637 61764 61051 61138 61866 61834 61619 61760 61122 61853 61816 61893 61613
Siemens Medical Solutions USA, Inc is recalling Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to vis due to Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacl. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
Recommended Action
Per FDA guidance
On January 8, 2020, the firm initiated the recall, notifying customers via Urgent Medical Device Correction letters. Customers were advised of the potential for a system collision due to incorrect use of the bypass key overriding the built-in collision control. The bypass key is intended to enable movement of an otherwise blocked system to avert immediate hazard, e.g. to recover a patient following device error or in case of emergency. It is not intended for permanent use. Customers were instructed to use the bypass key exclusively to avert an immediate hazard and immediately contact Siemens Customer Service at 1-800-888-7436 to fix the issue. Siemens Healthineers will correct the error with a field software update which will be available starting in January 2020, free of charge. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action when the software update is available for your system. Customers may contact the firm's service organization for an earlier appointment at 1-800-888-7436. With this field software update, an additional acoustic signal will be introduced for an event of movement in an error situation. The signal alerts the user that the system is in the "override" state and special attention should be paid regarding possible collisions. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026