Z-2641-2026Class II

ARTIS icono biplane. Model Number: 11327600

Name: Z-2641-2026 ARTIS icono biplane. Model Number: 11327600
Creator: Siemens Medical Solutions USA, Inc
Published: 2026-05-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2026-05-20 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS icono biplane. Model Number: 11327600 on 2026-05-20. FDA classified it as Class II and gives the reason as "Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits". 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-2641-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-20
Posted: 2026-07-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS icono biplane. Model Number: 11327600.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Root cause tag: software
FDA 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. The service organization will contact consignees in the near future to arrange a date to perform the corrective action. Additionally, consignees were instructed to confirm and acknowledge receipt of the recall notification digitally.
Quantity in commerce: 85 units
Distribution: US Nationwide distribution.
Product codes and lots: Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246, 184241, 184086, 184178, 184108, 184099, 184070, 184127, 184095, 184167, 184184, 184205, 184199, 184221, 184126, 184047, 184093, 184044, 184096, 184214, 184100, 184119, 184073, 184188, 184134, 184150, 184081, 184153, 184085, 184243, 184117, 184045, 184159, 184151, 184177, 184079, 184087, 184169, 184116, 184157, 184163, 184123, 184090, 184118, 184140, 184230, 184224, 184195, 184248, 184225, 184190, 184106, 184046, 184078, 184200, 184142, 184138, 184166, 184152, 184113, 184186, 184196, 184105, 184102, 184147, 184120, 184121, 184124, 184211, 184233, 184216, 184050, 184067, 184112, 184122, 184220, 184089, 184097, 184234, 184103, 184098, 184084, 184183, 184179, 184109

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2641-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2641-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2642-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2643-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

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)