Recall Z-1144-2021 ยท OWB Interventional Fluoroscopic X-Ray System
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.
| Date | Dec 18, 2020 |
| Status | Terminated |
| 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 s |
| Quantity | 41 U.S |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193326 | ARTIS Icono Siemens Medical Solutions USA, Inc., Apr 16, 2020 |