Recall Z-0298-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
| Date | Sep 21, 2020 |
| Status | Terminated |
| Reason | Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution). |
| Root cause | Component design/selection |
| Action | Siemens issued Urgent Medical Device Correction notification letter dated 9/22/20 via AX053/20/S stating reason for recall, health risk and action to take: Siemens will correct the error with a hardware replacement of the Display Port transceiver via Update Instruction AX052/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Pleas |
| Quantity | 22 units |
| Distribution | US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133580 | ARTIS ONE Siemens Medical Solutions USA, Inc., Apr 28, 2014 |