The Recall Desk
ModerateFDA (Devices)·Z-2341-2015·Announced 2015-08-12

Siemens Artis Q Systems Recalled for Potential Liquid Ingress

Siemens Medical Solutions is recalling Artis Q angiography systems because liquid may seep through the top cover, potentially disabling table movements. No injuries have been reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that no injuries have been reported and the hazard is limited to potential device malfunction (loss of table movement) rather than direct patient harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Artis Q 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 internal components. If this occurs, the table movements may no longer be possible.

The affected devices are distributed nationwide in the United States. Specific model numbers and serial numbers are listed in the recall documentation. The source text explicitly states that no injuries have been reported in connection with this issue.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Artis Q 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, general

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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