Recall Z-2643-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS icono floor. Model Number: 11327700.
| Date | Jul 1, 2026 (initiated May 20, 2026) |
| Status | Open, Classified |
| Reason | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. |
| Root cause | Software design |
| Action | Siemens notified consignees on about 05/19/2026 via letter. Consignees were instructed to ensure all users of the affected products within each organization and others who may need to be informed will receive the relevant safety information provided within the notice and comply with the recommendations therein, maintain the recall notification with product related records and until the corrective measures have been completed. Siemens will be releasing a software update to correct the issue via an Update Instruction AX018/26/S. All affected systems will be corrected by Siemens Healthineers. Th |
| Quantity | 30 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) Siemens Medical Solutions USA, Inc., Oct 22, 2024 |