Siemens Artis Zee and Zeego Fluoroscopic X-Ray System Recall
Siemens is recalling Artis Zee and Zeego fluoroscopic x-ray systems because a gap in the wireless foot switch housing could allow liquids to penetrate the interior, potentially causing the switch to fail.
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 agency classified this as a Class II recall. The hazard involves potential device failure due to liquid penetration, which is a functional defect rather than a direct, immediate physical injury hazard like fire or shock, fitting the Moderate category for low-risk contamination or functional issues without reported injuries.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Artis Zee and Zeego fluoroscopic x-ray systems. The recall involves 2,158 units distributed in the United States and 6,139 units worldwide.
The recall is due to a gap in the housing of the wireless foot switch that could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents, and/or bodily fluids. In rare cases, the introduction of liquids into the wireless foot switch housing could result in the failure of the foot switch.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue with the wireless foot switch.
The recalled product
- Product
- Artis Zee and Zeego fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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