Siemens Artis zee Biplane Recalled for Generator Power Supply Tolerance Issue
Siemens is recalling 268 Artis zee biplanes because a power supply tolerance issue may cause generator failure, preventing X-ray production 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. The hazard involves a functional failure that prevents X-ray production during procedures, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 268 units of the Artis zee biplane, Model Number 10094141. The recall is due to a tolerance issue in the power supply of the generator control that may cause the generator A100 to fail.
When this failure occurs, the X-ray tube is not supplied with the required voltage, making it impossible to produce X-rays. The issue occurs sporadically and may happen during an ongoing procedure. The affected units were distributed nationwide in the United States.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Siemens is the recalling firm and is responsible for addressing the defect.
The recalled product
- Product
- Artis zee biplane, Model Number 10094141
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 268
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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