Siemens Medical Solutions Recalls Wireless Foot Switches for X-Ray Systems
Siemens Medical Solutions is recalling wireless foot switches for Artis Q and Q.zen fluoroscopic systems because they 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. The hazard involves a functional failure that prevents fluoroscopic examinations, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,557 wireless foot switch accessories for Artis Q and Q.zen model interventional fluoroscopic x-ray systems. The affected model numbers are 4787797, 4787805, and 4787813. These units were distributed in 48 states, the District of Columbia, Guam, and Puerto Rico.
The recall is due to the possibility that the wireless foot switch may fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. While the hand switch provided can be used to release exposures, fluoroscopic examinations will not be possible if the foot switch is inoperable.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Siemens Medical Solutions is the recalling firm responsible for this action.
The recalled product
- Product
- Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 1,557
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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