Siemens Artis Q and Q.Zen Fluoroscopic X-Ray System Recall
Siemens is recalling Artis Q and Q.Zen 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 recall is classified as FDA Class II. 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, and no injuries are reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Artis Q and Q.Zen fluoroscopic x-ray systems. The recall involves 2,158 units distributed in the US and 6,139 units worldwide.
The recall is due to a gap in the housing of the wireless foot switch. This gap could potentially result in liquids, such as disinfectants, cleaning agents, or bodily fluids, penetrating the interior of the device. In rare cases, the introduction of these liquids could result in the failure of the foot switch.
The affected devices are identified by Device Model 4787797 and specific serial numbers listed in the official recall notice. Users should check their device serial numbers against the provided list to determine if their unit is affected.
The recalled product
- Product
- Artis Q and Q.Zen 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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