Recall Z-0400-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
| Date | Nov 4, 2020 (initiated Sep 18, 2020) |
| Status | Terminated |
| Reason | There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization o |
| Root cause | Software design |
| Action | A letter was sent to all affected customers on 09/18/2020 stating the following: Users are strongly recommended to not start releasing the x-ray for DSA (e.g. by pressing the pedal of the foot switch) until the system reaches the target position and has stopped moving. Siemens will correct this issue with a software patch via Update Instruction AX061/20/S. Siemens service organization will contact their affected customers to arrange a date to update the software. Customers can contact Siemens service organization for an earlier appointment by calling 1-800-888-7436. Following the correction, |
| Quantity | 100 distributed worldwide. 31 distributed nationwide in 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 |