Z-0523-2024Class II

ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

Name: Z-0523-2024 ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Creator: Siemens Medical Solutions USA, Inc
Published: 2023-10-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2023-10-17 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100 on 2023-10-17. FDA classified it as Class II and gives the reason as "Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and...". 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-0523-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-17
Posted: 2023-12-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
Root cause tag: design
FDA root cause: Component design/selection
Action: On October 17, 2023, the firm issued an URGENT MEDICAL DEVICE CORRECTION letter to affected customers. According to the firm's letter, as the unintended behavior is caused by thermal startup effects, its occurrence can be avoided by only switching off the system for a short time. The firm suggests keeping the system running (except during proposed weekly reboot) if availability for treatment of emergency patients is necessary. Please plan for up to half an hour warm-up time after switching on the system. The firm will contact affected customers to modify the mounting of the tube cover to mitigate the probability of occurrence of the issue. You may contact the firm's service organization for an earlier appointment at 1-800-888-7436.
Quantity in commerce: 38 worldwide, 11 US
Distribution: US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
Product codes and lots: UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0523-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0523-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-09

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)