FDA Device recall Z-1144-2021
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for singl…
- FDA Device
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for singl… by Siemens Medical Solutions Usa, citing 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 Sys….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1144-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-18 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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.
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
Identifiers
| code_info | Software version VE20B. Serial Numbers: Serial 180054 180062 180019 180065 180056 180057 180041 180084 18003…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1144-2021%22
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