Recall Z-2257-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
| Date | Apr 23, 2020 |
| Status | Terminated |
| Reason | Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient |
| Root cause | Software design |
| Action | Siemens issued Urgent Medical Device Correction (AX035/20/S) dated 4/23/20. The letter states reason for recall health risk and action to take: We urgently recommend not to use Quantification Application (QVA/QCA) on DSA images until the software problem has been resolved. If Quantification Application has already been used on DSA images in the past, please verify the results and diagnostic evaluation if applicable. Siemens will correct the error with a software patch via Update Instruction AX034/20/S. Our service organization will contact you shortly to arrange a date to perform this correc |
| Quantity | 5 US |
| Distribution | AZ, IL, UT, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193326 | ARTIS Icono Siemens Medical Solutions USA, Inc., Apr 16, 2020 |