Recall Z-2648-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS icono ceiling. Model Number: 11328100.
| Date | Jul 1, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| Reason | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen. |
| Root cause | Device Design |
| Action | Siemens Healthineers notified consignees on about 06/08/2026 via "CUSTOMER SAFETY ADVISORY NOTICE" letter. Consignees were instructed to conduct regular inspections of the gap between the monitor carrier and the ceiling-mounted arm and be attentive to any unusual noises, shaking, wobbling, or other unexpected behavior during system operation, as these may indicate loose screws. If any such signs are observed, limit movements of the DCS and contact Siemens service organization immediately for further instructions. Always ensure that the DCS is positioned for safe use. All affected systems wil |
| Quantity | 57 units |
| Distribution | US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221516 | ARTIS icono (Ceiling Configuration) Siemens Medical Solutions USA, Inc., Jul 19, 2022 |