Siemens Artis zeego X-ray Generator Recall for Power Supply Tolerance Issue
Siemens Medical Solutions is recalling 117 Artis zeego units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
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, and the hazard involves a functional failure that prevents X-ray imaging but does not report direct physical injury or death.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 117 units of the Artis zeego, Model Number 10280959, due to a tolerance issue in the power supply of the generator control. The affected units were distributed nationwide in the United States.
The tolerance issue may cause the generator A100 to fail if the control exceeds a specific value. When this failure occurs, the X-ray tube is not supplied with the required voltage, making it impossible to perform X-ray imaging. The issue occurs sporadically and may happen during an ongoing procedure.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Siemens Medical Solutions is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Artis zeego, Model Number 10280959
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 117
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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