Z-2529-2025Class II

Artis Pheno. Image-Intensified Flouroscopic X-Ray System

Name: Z-2529-2025 Artis Pheno. Image-Intensified Flouroscopic X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2025-08-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2025-08-12 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Pheno. Image-Intensified Flouroscopic X-Ray System on 2025-08-12. FDA classified it as Class II and gives the reason as "Limited system movements after startup". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2529-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-12
Posted: 2025-09-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Limited system movements after startup .
Root cause tag: software
FDA 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 [email protected] or by certified mail.
Quantity in commerce: 20 units
Distribution: US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2529-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2529-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05

Product code OWB

K241572Class IIARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc. / cleared 2024-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)