The Recall Desk
HighFDA (Devices)·Z-2342-2015·Announced 2015-08-12

Siemens Axiom Artis Angiography Systems Recalled for Liquid Seepage Risk

Siemens Medical Solutions is recalling Axiom Artis angiography systems because liquid may seep through the top cover and penetrate internal components, potentially disabling table movements.

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 involves a risk-of-harm product where injury has not yet been reported, which corresponds to a score of 3 (High) according to the rubric.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Axiom Artis dedicated angiography systems. These systems are used for single and biplane diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography, as well as whole-body radiographic and fluoroscopic procedures.

The recall is due to a risk that a large amount of liquid may seep through the top cover of the table and penetrate the components inside. If this occurs, the table movements may no longer be possible. The source text states that no injuries have been reported.

The affected units are distributed nationwide in the United States. Specific model numbers and serial numbers are listed in the official recall documentation. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue.

The recalled product

Product
Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, gene

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.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · liquid seepage

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