Siemens Medical Solutions USA, Inc ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Software version VE20B. Serial Numbers: Serial 180054 180062 180019 180065 180056 180057 180041 180084 180034 180072 180060 170026 180070 180048 180083 180080 180067 180040 180029 170023 180068 170025 180018 180047 180046 180085 180035 180081 170051 170027 180043 170053 180049 180077 180053 180055 180015 180014 180066 180082 180037
Siemens Medical Solutions USA, Inc is recalling ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version V due to Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system
Recommended Action
Per FDA guidance
Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice to all affected customers via AX080/20/S. on 12/28/20. Letter states reason for recall, health risk and action to take: Siemens will provide a software update to all affected customers which will correct the issue via Update Instruction AX070/20/S. The Operator Manual addendum to the Instruction for Use for VE20 has been updated and includes the missing information about the grid indication Our service organization will contact you to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436.
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