Siemens AXIOM Artis dFC X-ray Generator Recall for Power Supply Issue
Siemens is recalling 19 AXIOM Artis dFC units because a power supply tolerance issue may cause generator failure, preventing X-ray 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional failure of a medical device that prevents necessary procedures, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 19 units of the AXIOM Artis dFC, Model Number 7727717, 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, resulting in the X-ray tube not receiving the required voltage. Consequently, X-ray imaging will not be possible. The source notes that the issue occurs sporadically but may happen during an ongoing procedure.
The recall is classified as Class II by the FDA. No specific instructions for consumers are provided in the source text, but the recall number is Z-2025-2019.
The recalled product
- Product
- AXIOM Artis dFC, Model Number 7727717
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 19
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.
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