Siemens Axiom Artis Fluoroscopic Foot Switch Recalled for Potential Failure
Siemens is recalling 142 Axiom Artis fluoroscopic foot switches that may fail to release radiation due to external impacts.
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 describes a functional failure that prevents fluoroscopic examinations rather than a direct injury or death. No illnesses or injuries are reported, and the hazard is a loss of function rather than a physical safety threat like fire or shock.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 142 Axiom Artis model Interventional fluoroscopic x-ray foot switch accessories. The affected model numbers are 4787797, 4787805, and 4787813. These units were distributed in 50 states, the District of Columbia, Guam, and Puerto Rico.
The recall is due to a possibility that the wireless foot switch may fail if subjected to external factors, such as electrostatic discharge exceeding a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. While a hand switch can be used to release exposures, fluoroscopic examinations will not be possible if the foot switch is inoperable.
Healthcare facilities should identify the affected units by checking the serial numbers listed in the recall notice. Siemens is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 142
Distribution
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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