Siemens Artis zee X-ray System Recalled for Component Defect
Siemens is recalling specific Artis zee angiographic x-ray systems due to a component defect that can cause failures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific Artis zee angiographic x-ray systems. The recall involves systems equipped with an A100 Plus generator from a specific delivery lot and a 2-focus Megalix Cat Plus tube unit.
The recall is due to a component defect that can result in system failures. The source text does not specify the nature of the failures or any reported injuries or illnesses.
A total of 97 units were distributed worldwide, with 12 distributed in the United States. Affected units are located in Arkansas, Kansas, Michigan, Iowa, Illinois, Wisconsin, Minnesota, West Virginia, Ohio, and New York. Users should contact Siemens Medical Solutions USA, Inc. for further instructions.
The recalled product
- Product
- Artis zee,x-ray system, angiographic Artis zee 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 Ar
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
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