Siemens Artis Angiography Systems Recalled for Software Movement Blockage
Siemens is recalling Artis angiography systems because a software issue could block stand and table movements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 that could impede patient positioning, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific models of the Artis zee and Artis zeego angiography systems. The affected models include the Artis zee Biplane, Artis zee Ceiling, Artis zee Floor, and Artis zeego.
The recall is due to a software issue that could potentially cause the stand and table movements to be blocked. This defect affects the mechanical operation of the imaging equipment.
A total of 1,452 units are affected worldwide, with 638 units distributed in the United States. The products were distributed nationwide in the US. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this software issue.
The recalled product
- Product
- Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
- 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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Similar recalls
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- ModerateSiemens Artis zee Angiography System Software Recall
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