Siemens AXIOM Artis dBA X-ray Generator Recall for Power Supply Issue
Siemens is recalling 85 AXIOM Artis dBA units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.
What this means for you
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, and the hazard involves a risk of harm (procedure failure) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 85 units of the AXIOM Artis dBA, Model Number 7555357, 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 and preventing X-ray imaging.
The problem occurs sporadically but may happen during an ongoing procedure. The affected units were distributed nationwide in the United States. The recall is classified as Class II by the FDA.
Hospitals and medical facilities should identify affected units by checking the serial numbers listed in the official recall notice. Siemens is the recalling firm and is responsible for addressing the defect.
The recalled product
- Product
- AXIOM Artis dBA, Model Number 7555357
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 85
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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