Use cautionMedical device recall · FDA · Published June 19, 2023
Siemens ARTIS pheno-Angiography Systems Recall: Risk of Thermal Overload During Excessive
Siemens recalls ARTIS pheno-Angiography systems with specific serial numbers due to potential thermal overload in cable connectors during excessive fluoroscopy, risking imaging loss and treatment delays.
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
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Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens ARTIS pheno-Angiography Systems Recall: Risk of Thermal Overload During Excessive.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57830-siemens-artis-pheno-angiography-systems-recall-risk-of-thermal-overload. Based on FDA recall #Z-2361-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2361-2023%22&limit=1).
The FDA announced on June 19, 2023, that Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno-Angiography systems due to a hardware issue in cable connectors that may cause thermal overload. Owners should contact Siemens for repairs or replacements.
According to the FDA, a hardware issue in the cable connectors of the system generator may cause thermal overload during excessive fluoroscopy or acquisitions. This can result in a burning smell from the generator cabinet and loss of imaging functionality, potentially requiring cancellation of clinical treatment.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has had 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS Icono Biplane Recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the BD Pyxis MedStation ES Tower 352 Medication Cabinet Recall (April 30, 2026), the BD Pyxis Anesthesia Station ES REF 327 Medication Cabinet Recall (April 30, 2026), and the FUJIFILM FDR Visionary Suite CH-200 X-ray Device Recall (January 9, 2026).
How to tell if you have this one
Check the serial numbers listed: 164840, 164851, 164854, 164853, 164855, 164856, 164833, 164836, 164845, 164850. These systems were sold with specific model numbers and material numbers.
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 the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg, Macedonia, Mexico, Monaco, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Recall number
Product, codes & lots
Quantity
Z-2359-2023
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600; UDI-DI: 4056869063317 Serial Numbers: 180550 180517 180518 180546 180547 180560 180534 180556 180537 180545 180533 180566 180536 180563
14 units
Z-2360-2023
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700; UDI-DI: 4056869149325 Serial Numbers: 170561 170549 170559 170546 170552 170571 170570
7 units
Z-2361-2023
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000; UDI-DI: 4056869149325 Serial Numbers: Serial 164840 164851 164854 164853 164855 164856 164833 164836 164845 164850
10 units
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Identify if your system has one of the listed serial numbers: 164840, 164851, 164854, 164853, 164855, 164856, 164833, 164836, 164845, 164850.
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 the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg,…” 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 58 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-2361-2023 (June 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2361-2023 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.