Z-0516-2022Class II

Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

Name: Z-0516-2022 Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
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 icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600 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-0516-2022
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 icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
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: 72 units
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: 180062 180318 180054 180019 180065 180057 180041 180317 180034 180072 180349 180060 180337 180070 180048 180083 180369 180370 180345 180315 180343 180080 180301 180305 180067 180330 180040 180360 180333 180029 180352 180336 180316 180068 180363 180084 180334 180018 180350 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180021 180342 180321 180309 180356 180368 180341 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037 UDI: 04056869063317 Expanded Recall 12/20/21 S/N: 180056

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0516-2022
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

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)