Z-1497-2021Class II

Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS...

Name: Z-1497-2021 Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-03-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-03-19 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated... on 2021-03-19. FDA classified it as Class II and gives the reason as "Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1497-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-19
Posted: 2021-04-26
Terminated: 2021-11-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
Root cause tag: software
FDA root cause: Software design
Action: On 3/19/2021, Siemens Healthineers, issued an "URGENT: MEDICAL DEVICE CORRECTION" notice via letter dated 3/192021 to customers informing them of a possible hazard to patients, operators, or other persons and equipment due to a software error which affects ARTIS icono /pheno systems with software VE20C. The customer are instructed to do the following: The user should be aware of the limited system functionality in backup mode and bypass fluoroscopy operating mode (see also Operator Manual, Chapter 6.7: System Operating Modes). In some rare cases, the automatic recovery phase may not be successful within 4 minutes. If necessary, it may be continued with manual recovery according to the Operator Manual instructions, Chapter 3.13: Recovering functions in case of system failures. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. Promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. Siemens will update the affected software to prevent this non-conformity from reoccurring via Update Instruction AX023/21/S. 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. If you have any further questions, contact the Siemens Medical Solution USA, Inc., at 610-448-6478 or email: [email protected].
Quantity in commerce: 133 systems
Distribution: Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.
Product codes and lots: Software VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1497-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-26

Product code OWB

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)