Siemens Medical Solutions USA, Inc AXIOM Artis dBA, Model Number 7555357 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AXIOM Artis dBA, Model Number 7555357
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: 53181 53023 53167 53104 53067 53093 53162 53706 53058 53098 53253 53016 53188 53209 53223 53700 53017 53114 53063 53219 53033 53142 53116 53002 53086 53195 53165 53076 53064 53124 53176 53078 53111 53227 53202 53133 53140 53047 53710 53190 53180 53128 53185 53170 53187 53019 53141 53084 53074 53225 53215 53189 53056 53166 53149 53020 53096 53009 53147 53070 53049 53261 53122 53065 53031 53085 53026 53222 53090 53075 53256 53045 53057 53103 53182 53012 53022 53175 53194 53102 53109 53260 53043 53160 53117
Siemens Medical Solutions USA, Inc is recalling AXIOM Artis dBA, Model Number 7555357 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