Artis Pheno X-Ray System (Siemens) – Limited System Movement (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model No. 10849000, UDI: 04056869046877, Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097.
Products Sold
Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097.
Siemens Medical Solutions USA, Inc is recalling Artis Pheno. Image-Intensified Flouroscopic X-Ray System. due to Limited system movements after startup .. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Limited system movements after startup .
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026