Z-1339-2022Class II

syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono...

Name: Z-1339-2022 syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono...
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-02-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-02-25 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model... on 2022-02-25. FDA classified it as Class II and gives the reason as "After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1339-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-25
Posted: 2022-07-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via AX007/22/S dated 2/25/22. Letter states reason for recall, health risk and action to take: We do not consider it necessary to re-examine any patients previously treated using the syngo application software. Siemens will correct the software error via Update Instruction AX006/22/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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. 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: 127 units
Distribution: US Nationwide.
Product codes and lots: (1)Artis Pheno UDI-DI: 04056869046877 (2)Artis icono biplane UDI-DI: 04056869063317 (3) Artis icono floor- UDI-DI: 04056869149325 S/N: Serial 170319 180062 180054 180019 164719 164712 180065 180056 180057 180041 180421 180317 180034 164740 180349 180301 164722 180367 180382 180060 164311 170026 180337 164763 180070 180048 180083 164735 180087 180370 180371 180372 180345 180315 170367 170368 164723 180343 180080 180305 180330 170331 164743 180379 180386 164741 180360 180333 170349 170361 180029 180352 180336 180407 164728 180412 180400 180397 180316 180068 180363 170334 170336 180084 180418 180334 164711 170025 180018 180350 180376 180354 180046 180047 180335 180085 164321 180035 164718 180339 180357 180358 180361 180362 180081 180423 170346 180331 180411 180381 180021 180342 170365 170322 180321 180309 180356 180378 180393 164739 180368 180413 180341 164703 180323 170303 170378 180329 180053 180055 164721 180043 170053 180049 180377 180077 180086 180015 180014 164726 164724 164725 180066 180082 164760 180037 180373

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1339-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1339-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-06

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)