Recall Z-0614-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, INC
Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
| Date | Aug 22, 2017 |
| Status | Terminated |
| Reason | The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Urgent- Medical Device Correction letter dated August 22, 2017. Our service organization will contact you shortly to arrange a date to perform this corrective action (A system hardware update will be implemented and all affected DP Transceivers below revision 03 will be updated). Following the system hardware update, the cause is eliminated and a recurrence of the fault is prevented. For further questions, please call (610) 448-6461. |
| Quantity | 207 worldwide (13 distributed in US) |
| Distribution | US Distribution to the states of : AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133580 | ARTIS ONE Siemens Medical Solutions USA, Inc., Apr 28, 2014 |