The Recall Desk
ModerateFDA (Devices)·Z-2033-2019·Announced 2019-07-31

Siemens Artis zee Biplane Recalled for Power Supply Tolerance Issue

Siemens Medical Solutions is recalling three Artis zee biplane MN units due to a power supply tolerance 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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional failure preventing X-ray generation, which fits the criteria for a moderate severity recall without reported harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling three units of the Artis zee biplane MN, Model Number 10094143. The affected devices have serial numbers 149202, 149100, and 149106. These units were 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 source notes that the issue occurs sporadically but may happen during an ongoing procedure.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect.

The recalled product

Product
Artis zee biplane MN, Model Number 10094143
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: 149202 149100 149106

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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