Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2015-2019·Announced 2019-07-31

Siemens AXIOM Artis BC X-ray Generator Recall Due to Power Supply Issue

Siemens is recalling six AXIOM Artis BC units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 produce X-rays) rather than a direct physical injury risk, and no injuries are reported, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling six units of the AXIOM Artis BC, Model Number 5904649. The affected units were distributed nationwide in the United States. The specific serial numbers for the recalled units are 14101, 14111, 14108, 14099, 14094, and 14112.

The recall is due to a tolerance issue in the power supply of the generator control. If the issue occurs above a specific value, it may cause the generator A100 to fail. When this happens, the X-ray tube is not supplied with the required voltage, making it impossible to produce X-rays. The issue occurs sporadically but may happen during an ongoing procedure.

This recall is classified as Class II by the FDA. No injuries or illnesses have been reported in the source text. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect.

The recalled product

Product: AXIOM Artis BC, Model Number 5904649
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — X-ray Equipment
Hazard: equipment-failure
Affected units: 6

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: 14101 14111 14108 14099 14094 14112

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 →

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