Recall Z-2529-2025 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
| Date | Sep 5, 2025 (initiated Aug 12, 2025) |
| Status | Open, Classified |
| Reason | Limited system movements after startup . |
| Root cause | Software design |
| Action | Consignees were mailed an URGENT: MEDICAL DEVICE CORRECTION notification dated 8/12/25. The notification informs consignees that the recall issue will be corrected via release of an Update Instruction AX032/25/S by appointment, which can be arranged by contacting 1-800-888-7436. Consignees are to disseminate the recall notification to all users of affected devices within their organization and to where product may be further distributed. Consignees are to return the completed recall response form via email to recallsandrefusals.team@siemens-healthineers.com or by certified mail. |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT. |
| 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 |