Recalls / —

—#215610

Product

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

FDA product code

OWB — Interventional Fluoroscopic X-Ray System

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K241572

Affected lot / code info

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.

Why it was recalled

Limited system movements after startup .

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.

Timeline

Recall initiated

2025-08-12

Posted by FDA

2025-09-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #215610. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.