Siemens Artis X-Ray Systems Recalled for Overvoltage Protection Defect
Siemens is recalling 26 Artis X-ray systems worldwide because incorrect diodes may fail to protect against overvoltage, potentially causing system malfunction.
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, and the source text describes a potential functional failure during overvoltage without reporting any injuries, illnesses, or deaths, aligning with the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 26 units of the Artis zee floor, Artis Q ceiling, and Artis Q.zen ceiling Image-Intensified Fluoroscopic X-Ray Systems. The recall affects serial numbers 109762, 111158, 124344, and 111161. These systems are used for diagnostic imaging and interventional procedures.
The recall is due to a defect in the electronic components within the generator. Some units were equipped with an incorrect protection diode, which may result in inadequate protection against overvoltage. Consequently, the system may not function properly if an overvoltage situation occurs.
The affected units were distributed worldwide, including 4 units in the United States. The US distribution included Arkansas, California, Iowa, and Illinois. The remaining units were distributed in China, Germany, India, Indonesia, Italy, Japan, the Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and the United Kingdom. Users should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the repair or replacement of the affected components.
The recalled product
- Product
- Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and
- Manufacturer
- Siemens Medical Solutions USA, Inc
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 (1)
- Serial numbers 109762 111158 124344 111161
Distribution
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