The Recall Desk
ModerateFDA (Devices)·Z-2021-2019·Announced 2019-07-31

Siemens AXIOM Artis dTC X-ray Generator Recall for Power Supply Defect

Siemens is recalling 98 AXIOM Artis dTC units because a power supply tolerance issue may cause generator failure, preventing X-ray imaging.

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 (inability to perform X-ray) rather than a direct physical injury or death risk, fitting the 'voluntary precautionary recalls' or 'low-risk' criteria for moderate severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 98 units of the AXIOM Artis dTC, Model Number 7413078, due to a tolerance issue in the power supply of the generator control. This defect may cause the generator A100 to fail, resulting in the X-ray tube not receiving the required voltage and making X-ray imaging impossible.

The issue occurs sporadically but may happen during an ongoing procedure. The affected units were distributed nationwide in the United States. Specific serial numbers for the recalled units are listed in the agency's recall record.

Hospitals and medical facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this defect. Patients who have had procedures on these devices should consult their healthcare providers if they have concerns about the imaging results.

The recalled product

Product
AXIOM Artis dTC, Model Number 7413078
Affected units
98

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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