Z-2648-2026Class II

ARTIS icono ceiling. Model Number: 11328100

Name: Z-2648-2026 ARTIS icono ceiling. Model Number: 11328100
Creator: Siemens Medical Solutions USA, Inc
Published: 2026-06-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2026-06-08 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS icono ceiling. Model Number: 11328100 on 2026-06-08. FDA classified it as Class II and gives the reason as "Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2648-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-07-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS icono ceiling. Model Number: 11328100.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthineers notified consignees on about 06/08/2026 via "CUSTOMER SAFETY ADVISORY NOTICE" letter. Consignees were instructed to conduct regular inspections of the gap between the monitor carrier and the ceiling-mounted arm and be attentive to any unusual noises, shaking, wobbling, or other unexpected behavior during system operation, as these may indicate loose screws. If any such signs are observed, limit movements of the DCS and contact Siemens service organization immediately for further instructions. Always ensure that the DCS is positioned for safe use. All affected systems will be corrected by Siemens Healthineers service engineers. Siemens engineers will correct the screwed connection of the monitor ceiling support according to the adapted specifications and instructions. The correction will be released via an Update Instruction AX022/26/S. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
Quantity in commerce: 57 units
Distribution: US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
Product codes and lots: Model Number: 11328100. UDI-DI: 4056869295923.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2648-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2648-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code OWB

K221516Class IIARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc. / cleared 2022-07-19

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)