Siemens Medical Solutions USA, Inc Artis zee floor, Model Number 10094135 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artis zee floor, Model Number 10094135
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: 135944 135746 135120 135322 135757 136513 136562 135914 135102 136042 135927 135986 135935 135953 135841 135200 135201 135279 135169 135879 135229 135157 136113 135990 136077 136103 135862 135235 135117 135358 135920 136168 135148 135366 136568 135843 135111 135112 135779 136224 135137 136607 136579 135309 124007 124015 136280 136286 135109 135413 135144 135145 136362 135404 136318 136234 135151 135421 135264 135199 135760 136500 136515 135217 136031 136032 135124 135125 136084 136026 136479 135179 135394 135285 136338 136196 135245 135420 136384 136387 136488 135770 136550 136256 136408 136450 136508 136547 135788 136242 136383 136517 135406 136043 136586 135129 135416 135909 135222 136393 136520 135258 135260 135755 136548 135143 135114 135133 136350 135353 135253 135375 135772 136483 136555 135190 135881 136614 137384 136567 135714 135922 136314 136190 136197 136254 135813 135791 136561 135302 135152 136505 135182 124006 135868 135793 135132 135723 136126 135847 135281 135373 135196 136128 136147 136557 136558 136391 136503 136143 135352 135388 135384 136582 136345 136570 135954 136459 136518 135771 136290 136609 135233 136594 135203 136137 135286 135397 136278 135424
Siemens Medical Solutions USA, Inc is recalling Artis zee floor, Model Number 10094135 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