ARTIS is a family of dedicated angiography systems… recallZ-2019-2025 · Siemens Medical Solutions USA, Inc · initiated May 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
Siemens Healthineers sent customers a Customer Advisory Notice dated May 15, 2025 informing customers of a potential issue with ARTIS pheno and ARTIS icono systems with the following model numbers: ARTIS pheno 10849000, ARTIS icono biplane 11327600, ARTIS icono ceiling 11328100, ARTIS icono floor 11327700; due to in very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose and appropriate software update will be implemented, based on the current software version of the affected system.
Recall details
- Recall number
- Z-2019-2025
- Status
- Open, Classified
- Initiated by the company
- May 15, 2025
- Posted by the FDA
- Jun 27, 2025
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product code
- OWB
- FDA submissions
- K230949
- Distribution
- Worldwide.
Product description
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e., patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.
Code information (models, lots, serial numbers)
4056869046877
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARTIS pheno 10849000Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system14 recalls64 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97135).
- Z-2020-2025 · Open, Classifiedinterventional fluoroscopic x-ray system
- Z-2021-2025 · Open, Classifiedinterventional fluoroscopic x-ray system
- Z-2022-2025 · Open, Classifiedinterventional fluoroscopic x-ray system
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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