Siemens Artis zee/zeego Angiographic X-ray Systems Recalled for Footswitch Defect
Siemens is recalling Artis zee/zeego angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.
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 functional defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Artis zee/zeego angiographic x-ray systems. The recall involves 4,657 systems distributed worldwide, including nationwide distribution in the United States. The affected model numbers are 10094135, 10094137, 10094139, 10094141, and 10280959.
The recall was initiated because the semi-automatic focus switch may not work as intended when the footswitch is pressed multiple times. This defect could potentially affect the performance of the imaging system during procedures.
Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect. The source text does not specify a particular action for consumers, as these are professional medical devices.
The recalled product
- Product
- Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 4,657
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model Numbers: 10094135
- 10094137
- 10094139
- 10094141
- 10280959
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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