Z-0515-2022Class II

Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000

Name: Z-0515-2022 Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-10-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-10-12 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 on 2021-10-12. FDA classified it as Class II and gives the reason as "Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be...". 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-0515-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-12
Posted: 2022-01-21
Terminated: 2024-04-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued A Customer Safety Advisory Notice dated 10/12/21 to affected customers via AX047/21/S. Additionally, a software update will be initiated for all affected users via Update Instruction AX046/21/S. Letter states reason for recall, health risk and action to take: To avoid inaccurate measurement values, repeat the distance measurements after changing the Auto TOD Calibration or Distance Calibration of the scene. Additionally, before closing the image after performing the calibration, create a screenshot/secondary capture image for post review. The Operator Manual of the affected systems will be updated according to the information mentioned above. This is regarded as an interim solution until the next software update is available. The Operator Manual update will draw attention to the issue. We do not consider it necessary to re-examine any patients in relation to the issues (issue 1 to 4) described above. If measurements have already been performed in the past for diagnostics, please verify the results and diagnostic evaluation if applicable. Siemens will correct the software error via Update Instruction AX046/21/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.
Quantity in commerce: 12 units
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: 164719 164712 164722 164723 164728 164711 164718 164703 164721 164726 164724 164725 UDI: 04056869046877

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0515-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0515-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-21
Z-0516-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-21
Z-0517-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-21

Product code OWB

K201156Class IIARTIS pheno (VE2)Siemens Medical Solution USA, Inc. / cleared 2020-06-29

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)