Siemens Artis One X-Ray System Recalled for Data Mirroring Error
Siemens is recalling one Artis One angiography system because imported left atrium segmentation results may be incorrectly mirrored to a 3D mapping system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a data integrity issue (mirroring) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one Artis One Interventional Fluoroscopic x-ray system. The recall is due to a software issue where imported segmentation results of the left atrium may be mirrored when transferred to an electro-anatomical 3D mapping system, specifically the CARTO system from Biosense Webster Inc.
The affected unit is identified by Serial # 82010 and material # 10848600. The distribution pattern is listed as nationwide distribution to Michigan only. The source text does not report any injuries, illnesses, or deaths associated with this defect.
Hospitals and facilities using the affected system should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the data mirroring issue.
The recalled product
- Product
- Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardia
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging System
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial # 82010
- material # 10848600
Distribution
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