Siemens Medical Solutions Recalls Artis zee and Artis zeego Foot Switches
Siemens Medical Solutions is recalling 510 foot switch accessories for Artis zee and Artis zeego x-ray systems because they may fail to release radiation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (failure to release radiation) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 510 units of the Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory. The affected model numbers are 4787797, 4787805, and 4787813. These units were distributed across 48 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 impacts, such as electrostatic discharge exceeding a certain intensity. If the foot switch fails, it will no longer be able to release radiation. While a provided hand switch can be used to release exposures, fluoroscopic examinations will not be possible if the foot switch is non-functional.
Healthcare facilities should check their inventory for the specific model and serial numbers listed in the recall notice. Siemens Medical Solutions USA, Inc. is the recalling firm responsible for this action.
The recalled product
- Product
- Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 510
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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