The Recall Desk
ModerateFDA (Devices)·Z-2032-2019·Announced 2019-07-31

Siemens Artis zee floor MN X-ray generator recall

Siemens is recalling 23 Artis zee floor MN units due to a power supply tolerance issue that may cause generator failure and prevent 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, and the hazard is a functional failure preventing X-ray imaging rather than a direct physical injury or contamination risk.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 23 units of the Artis zee floor MN, Model Number 10094142. The recall is due to a tolerance issue in the power supply of the generator control that may cause generator A100 failure. This failure prevents the X-ray tube from receiving the required voltage, making X-ray imaging impossible.

The issue occurs sporadically and may happen during an ongoing procedure. The affected units were distributed nationwide in the United States. Specific serial numbers for the affected units are listed in the recall documentation.

Hospitals and medical facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that the defect may cause temporary or medically reversible health consequences.

The recalled product

Product
Artis zee floor MN, Model Number 10094142
Affected units
23

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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