The Recall Desk
HighFDA (Devices)·Z-2340-2015·Announced 2015-08-12

Siemens Artis zee Systems Recalled for Potential Liquid Seepage

Siemens Medical Solutions is recalling Artis zee angiography systems because liquid may seep through the table cover, potentially preventing table movement.

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 (medical device) where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Siemens Artis zee systems, which are dedicated angiography systems used for diagnostic imaging and interventional procedures. The recall is due to a defect where a large amount of liquid may seep through the top cover of the table and penetrate the internal components.

If this liquid seepage occurs, the table movements may no longer be possible. The source text explicitly states that no injuries have been reported in connection with this issue.

The recall covers units distributed nationwide in the US. Affected units are identified by specific model numbers and serial numbers listed in the official recall documentation. Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address the defect.

The recalled product

Product
Siemens Artis zee 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 angiograph

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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