Siemens Medical Solutions USA, Inc Artis zee floor MN, Model Number 10094142 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artis zee floor MN, Model Number 10094142
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: 140212 140115 140101 140205 140213 140204 140209 140219 140224 140218 140221 140220 140206 140223 140105 140226 140108 140102 140109 140100 140202 140214 140114
Siemens Medical Solutions USA, Inc is recalling Artis zee floor MN, Model Number 10094142 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