The Recall Desk
ModerateFDA (Devices)·Z-2019-2019·Announced 2019-07-31

Siemens AXIOM Artis dTA X-ray Generator Recall

Siemens is recalling 178 AXIOM Artis dTA units due to a power supply issue that may prevent X-ray generation during procedures.

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 hazard is a functional failure preventing imaging rather than a direct physical injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 178 units of the AXIOM Artis dTA, Model Number 7008605. The recall covers units distributed nationwide in the United States.

The recall is due to a tolerance issue in the power supply of the generator control. This issue may cause the generator A100 to fail, resulting in the X-ray tube not receiving the required voltage. Consequently, X-ray imaging may not be possible. The issue occurs sporadically and may happen during an ongoing procedure.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue with the affected units.

The recalled product

Product
AXIOM Artis dTA, Model Number 7008605
Affected units
178

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 23 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 23 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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