FDA Medical Device Recalls (openFDA)
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 number
- Z-1144-2021
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Status
- Terminated
- Initiated
- 2020-12-18
- Posted
- not on file
- Terminated
- 2021-11-17
- Reason
- 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
- Root cause
- Software design
- Action
- 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.
- Quantity
- 41 U.S
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K193326"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28