Z-2257-2020Class II

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an...

Name: Z-2257-2020 ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-04-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-04-23 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number... on 2020-04-23. FDA classified it as Class II and gives the reason as "Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the...". 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-2257-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-23
Posted: 2020-06-03
Terminated: 2020-10-26
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued Urgent Medical Device Correction (AX035/20/S) dated 4/23/20. The letter states reason for recall health risk and action to take: We urgently recommend not to use Quantification Application (QVA/QCA) on DSA images until the software problem has been resolved. If Quantification Application has already been used on DSA images in the past, please verify the results and diagnostic evaluation if applicable. Siemens will correct the error with a software patch via Update Instruction AX034/20/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.
Quantity in commerce: 5 US
Distribution: AZ, IL, UT, WI
Product codes and lots: Serial Numbers: 180014 180015 180018 180019 180029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2257-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2257-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-03

Product code OWB

K193326Class IIARTIS IconoSiemens Medical Solutions USA, Inc. / cleared 2020-04-16

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)