interventional fluoroscopic x-ray system recallZ-2020-2025 · 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-2020-2025
- 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
- K241572
- Distribution
- Worldwide.
Product description
interventional fluoroscopic x-ray system
Code information (models, lots, serial numbers)
4056869063317
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
Other devices under the same FDA submission
3 devices cleared under K241572 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- ARTIS pheno 10849000Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system14 recalls64 reports
- ARTIS icono ceiling 11328100Siemens Healthcare GmbH · System, x-ray, angiographic9 recalls1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 97135).
- Z-2019-2025 · Open, ClassifiedARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and ob…
- 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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