Z-2359-2023Class II

ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and...

Name: Z-2359-2023 ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2023-06-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2023-06-19 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600 on 2023-06-19. FDA classified it as Class II and gives the reason as "Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2359-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-19
Posted: 2023-08-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens issued Urgent: Medical Device Correction to all users of ARTIS icono/ ARTIS pheno systems with a specific Polydoros ACX power generator on 6/19/23. Letter states reason for recall, health risk and action to take: It is strongly recommended to establish appropriate emergency procedures until the corrective action has been performed. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Siemens will correct the hardware error via Update Instruction AX008/23/S. This measure will correct the Polydoros ACX reactor coil of all affected systems. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
Quantity in commerce: 14 units
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg, Macedonia, Mexico, Monaco, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Product codes and lots: UDI-DI: 4056869063317 Serial Numbers: 180550 180517 180518 180546 180547 180560 180534 180556 180537 180545 180533 180566 180536 180563

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2359-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2359-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-08
Z-2360-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-08
Z-2361-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-08

Product code OWB

K220432Class IIARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc. / cleared 2022-06-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)