Siemens Medical Solutions USA, Inc Artis zee biplane, Model Number 10094141 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artis zee biplane, Model Number 10094141
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: 153131 153229 153172 153315 153317 153992 153335 153695 153101 153102 153717 153779 153280 153648 153674 153166 153700 154096 153834 153194 153169 153803 153110 153890 154157 153199 153887 153269 154074 154012 153191 153252 153732 153239 154090 153227 153889 153655 153234 153236 153285 154686 153273 153251 153254 153344 154095 153342 154093 153171 153197 153916 153831 153256 153154 154086 153139 153882 153311 153211 153118 153987 153740 153863 153772 154079 153965 153707 154098 154073 153263 153276 154076 153758 131013 153257 154156 153351 153112 153155 153245 153318 153720 153998 153271 153857 153226 153939 153951 153290 153678 153679 153277 153125 153128 153134 153135 153743 153967 153946 153145 153866 153868 153829 153148 131021 153878 153906 153959 153709 153767 153217 153639 153119 153164 153304 153869 153719 153232 131005 153770 154020 153930 153728 153355 154058 153811 153225 154155 153883 153875 153289 153664 153963 153824 154034 154018 153356 153701 153113 153235 153347 153708 153338 154066 153259 153314 154014 153988 154048 153716 153215 153922 153870 153107 153178 153249 153706 153860 153264 153157 153903 153908 153819 154087 153914 154085 153156 153697 131000 153147 153790 153928 153864 153159 153756 153808 154052 153797 153634 154028 154084 153201 153865 153640 153714 153736 153832 153913 153348 153220 153947 153657 153873 153109 153150 153299 153757 153898 154075 154064 153111 153618 153689 154044 153847 154056 154035 153999 153124 153682 153120 153122 153329 153173 153763 153686 154100 154082 153617 153327 153180 153818 154007 153323 154055 154067 154088 131020 153762 153270 153862 153670 153607 153760 154094 153265 153694 153886 153332 153141 153195 153920 153343 153975 153993 153325 153631 153160 153186 153729 154089 153354 153684 153799 154041 153742 153952 154077 153214 153722 153206 153255 154097 153115 153744 153827 153671
Siemens Medical Solutions USA, Inc is recalling Artis zee biplane, Model Number 10094141 due to A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube wi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Recommended Action
Per FDA guidance
Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. In the event the issue occurs, the system cannot be operated normally as X-ray will not possible. Planned procedures may have to be terminated and performed on an alternative X-ray system. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all potentially affected users of the Artis Zee and AXIOM Artis systems with generator A100 via Update Instruction AX038/18/S. The Siemens Service organization will modify the affected supply circuit and revise the wiring. This modification will bring the voltage back to the center of the tolerance range. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. 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