The Recall Desk
ModerateFDA (Devices)·Z-2024-2019·Announced 2019-07-31

Siemens AXIOM Artis dFA Recalled for Power Supply Tolerance Issue

Siemens is recalling 39 AXIOM Artis dFA units because a power supply issue may cause generator failure, preventing X-ray production 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 source text describes a functional failure that prevents X-ray production without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 39 units of the AXIOM Artis dFA, Model Number 7555373, due to a tolerance issue in the power supply of the generator control. The affected units were distributed nationwide in the United States.

The issue may cause the generator A100 to fail if the tolerance exceeds a specific value. When this failure occurs, the X-ray tube is not supplied with the required voltage, making it impossible to produce X-rays. The problem occurs sporadically but may happen during an ongoing procedure.

No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.

The recalled product

Product
AXIOM Artis dFA, Model Number 7555373
Affected units
39

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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