Z-1646-2022Class II

Artis pheno- Model No. 10849000

Name: Z-1646-2022 Artis pheno- Model No. 10849000
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-08-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-08-10 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis pheno- Model No. 10849000 on 2022-08-10. FDA classified it as Class II and gives the reason as "Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1646-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-10
Posted: 2022-08-26
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis pheno- Model No. 10849000
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Root cause tag: design
FDA root cause: Device Design
Action: On August 10, 2022, the firm notified customers via "URGENT: MEDICAL DEVICE CORRECTION" Letter. Customers were advised that if the error occurs, the user should try to recover normal operation by a shutdown and restart of the system. Siemens will correct the error with a hardware modification via Update Instruction AX028/22/S and AX039/22/S. Siemens' service organization will contact customers 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, call 610-219-4834 or email: [email protected].
Quantity in commerce: 1,389 (590 US; 799 OUS) (Total)
Distribution: Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Inhouse Company; Indonesia; Ireland; Israel; India; Iran; Italy; Jordan; Japan; South Korea; Kuwait; Kazakhstan; Lebanon; Luxembourg; Monaco; Mongolia; Martinique; Mexico; Malaysia; Netherlands; Norway; New Zealand; Oman; Philippines; Poland; Portugal; Qatar; Serbia; Russian Federation; Saudi Arabia; Sweden; Singapore; Slovenia; Slovakia; El Salvador; Thailand; Turkey; Taiwan; Ukraine; Vietnam and South Africa.
Product codes and lots: UDI-DI: 04056869046877 Serial Numbers 164766 164140 164138 164287 164740 164210 164183 164184 164776 164312 164071 164034 164391 164763 164306 164735 164277 164095 164072 164771 164743 164048 164741 164241 164186 164069 164213 164728 164263 164060 164113 164398 164366 164279 164774 164074 164084 164086 164098 164153 164330 164389 164394 164772 164718 164163 164297 164778 164333 164377 164397 164300 164105 164227 164022 164250 164739 164703 164187 164211 164100 164097 164775 164303 164352 164726 164724 164760 164371 ***Updated 9/23/22*** 164794 164400 ***Updated 1/9/23*** 164793 164172 164795

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1646-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1645-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-26
Z-1646-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-26
Z-1647-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-26

Product code OWB

K220409Class IIARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc. / cleared 2022-06-29

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)