Lower risk Medical device recall · FDA · Published October 20, 2021

Siemens Artis Q.zen Ceiling Systems: Short Procedure Delays with X-ray Release

Siemens recalls Artis Q.zen ceiling systems with software VD12-angiography that may cause short procedure delays if x-ray release is interrupted during imaging. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0304-2022Medical device Siemens ›

Lower-risk recall

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418

✎ GovInfoNow plain-language explainer

Siemens is recalling Artis Q.zen ceiling systems with software VD12-angiography that could cause short delays in procedures if x-ray release is interrupted. This is a software issue that might affect imaging procedures but does not pose a serious safety risk. Read more at govinfonow.com/recall/61648-siemens-artis-q-zen-ceiling-systems-short-procedure-delays-with.

Source Summary by GovInfoNow · govinfonow.com/recall/61648-siemens-artis-q-zen-ceiling-systems-short-procedure-delays-with · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0304-2022

Cite this page

“Siemens Artis Q.zen Ceiling Systems: Short Procedure Delays with X-ray Release.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61648-siemens-artis-q-zen-ceiling-systems-short-procedure-delays-with. Based on FDA recall #Z-0304-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0304-2022%22&limit=1).

The FDA announced on Oct. 20, 2021, that Siemens Medical Solutions USA, Inc. is recalling Artis Q.zen ceiling systems with VD12-angiography software due to a potential procedure delay. The agency issued recall number Z-0304-2022 for the voluntary Class II action.

How to tell if you have it

Brand: Siemens
Product: Artis Q.zen ceiling with software VD12-angiography systems
Model Number: 10848354
Serial Numbers: 111502, 111503, 111510, 111507, 111512, 111508, 111133, 111504, 111506, 111513, 111500, 111501, 111505, 111514
Distribution: US Nationwide

The hazard

According to the FDA, if the source-to-image distance lift movement is activated and an x-ray is released simultaneously, the x-ray may not be possible. This results in a "No x-ray, try again" message and may cause a short delay in the procedure.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), Siemens ARTIS icono floor recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025), Canon Alphenix X-ray Systems Recall (Aug. 4, 2026), and Canon Alphenix INFX-8000V X-ray System Recall (Dec. 19, 2025).

How to tell if you have this one

Check for model number 10848354 or serial numbers listed: 111502, 111503, 111510, 111507, 111512, 111508, 111133, 111504, 111506, 111513, 111500, 111501, 111505, 111514.

Brand
Siemens
Category
Medical device

FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide Distribution

Recall number	Product, codes & lots	Quantity
Z-0296-2022	Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135; Serial Numbers: 124703 139012 139023	3 units
Z-0297-2022	Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137; Serial Numbers: Serial 150002 150017 125700 150005 150023 150009 150015 150003 Expanded Recall 11/15/21: 147120 147119 150011	8 units
Z-0298-2022	Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139; Serial Numbers: 159030 159034 159038 159032 159046 159054 159015 159058 159028 159037 159026 159042 159047 159025 159024 159021 159041 159049 159010 Expanded Recall 11/15/21: 159065	19 units
Z-0299-2022	Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141; Serial Numbers: 156011 156014	2 units
Z-0300-2022	Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280; Serial Numbers: Serial 104007 104016 104005 104027 104012 104025 104013 132500 Expanded Recall 11/15/21: 104029 104020	8 units
Z-0301-2022	Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281; Serial Numbers: 110088 110059 110103 110035 110046 110005 110058 110056 110062 109523 109645 110067 110095 110051 110001 110020 110007 110093 110069 110075 109627 110042 110043 110048 110061 110063 110064 110032 110047 110102 110039 110040 110023 110065 110052 110018 110072 110081 110036 110054 110053 110044 110031 110016 110037 110077 109497 110079 110099 110027 110049 110066 110024 110017 110025 110100 110083 110091 110006 110055 110026 110022 110000 133501 110057 110104 110041 Expanded Recall 11/15/21: 110096 110014	67 units
Z-0302-2022	Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282; Serial Numbers: 122025 122012 122022 122021 122005 121209 122017 122001 134500 122010 122007 122016 122013 122024 122014	15 units
Z-0303-2022	Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353; Serial Numbers: 105500 105503 105501	3 units
Z-0304-2022	Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354; Serial Numbers: Serial 111502 111503 111510 111507 111512 111508 111133 111504 111506 111513 111500 111501 111505 111514	15 units
Z-0305-2022	Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355; Serial Numbers: 123502 123501	2 units

Based on the official FDA remedy

What to do — step by step

Check System Status
Verify if the system displays a message saying 'No x-ray, try again' when x-ray release is interrupted during imaging procedures.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

Oct 20, 2021Firm started the recall
Nov 24, 2021FDA classified it Class II
Dec 1, 2021Published in FDA’s Enforcement Report
Jun 18, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this system?

No, the recall does not require stopping use. The issue causes only short delays in procedures.

Similar recalls

Latest medical device recalls

Keep exploring

More Siemens recalls

Link to this recall

<a href="https://govinfonow.com/recall/61648-siemens-artis-q-zen-ceiling-systems-short-procedure-delays-with">Siemens Artis Q.zen Ceiling Systems: Short Procedure Delays with X-ray Release (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0304-2022 (October 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0304-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.