Use cautionMedical device recall · FDA · Published August 10, 2022
Siemens Artis Icono X-ray Systems Recall: Potential Hardware Failure
Siemens recalls Artis Icono biplane and floor models with specific serial numbers due to rare risk of X-ray system shutdown if error detection fails. Affected units may require repair.
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.
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Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens Artis Icono X-ray Systems Recall: Potential Hardware Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60195-siemens-artis-icono-x-ray-systems-recall-potential-hardware-failure. Based on FDA recall #Z-1647-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1647-2022%22&limit=1).
The FDA announced on Aug. 10, 2022, that Siemens Medical Solutions USA, Inc. is recalling Artis icono biplane and floor X-ray systems due to a potential hardware issue with specific X-ray tube lots. This defect may prevent the release of X-rays if the error detection mechanism fails.
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.
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 ceiling recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include GE Optima XR240amx Mobile X-Ray System Recall (June 5, 2026), GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), and Philips Allura Cardio Vascular-Allura Centron X-Ray System Recall (June 17, 2026).
How to tell if you have this one
Check for Artis Icono biplane model 11327600 or floor model 11327700 with serial numbers listed in the recall notice. The recall includes specific serial numbers provided in the notice.
Brand
Siemens
Category
Medical device
FDA recall event · 3 products
All 3 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
Ongoing
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.
Verify your device's serial numbers against the list provided in the recall notice to confirm if it's affected.
Contact Siemens
Reach out to Siemens Medical Solutions USA, Inc. for guidance on next steps if your device is listed.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 28 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1647-2022 (August 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1647-2022 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.