Siemens Medical Solutions USA, Inc Recall 87169
Description: 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.
Siemens Medical Solutions USA, Inc Recall 87169 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1144-2021 |
| Event ID | 87169 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 41 U.S |
| Recall 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 |
| Device Classification | 20210303 |
| Device Code Info | 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 |
| Center Classification Date | 20210223 |
| Recall Initiation Date | 20201218 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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