ARTIS One X-Ray System (Siemens) – First Release Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARTIS One Angiographic X-Ray System
Brand
SIEMENS MEDICAL SOLUTIONS USA, INC
Lot Codes / Batch Numbers
Model Number 10848600
Products Sold
Model Number 10848600
SIEMENS MEDICAL SOLUTIONS USA, INC is recalling ARTIS One Angiographic X-Ray System due to A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be perfor. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026