Siemens Artis zee floor recalled for power supply tolerance issue
Siemens Medical Solutions is recalling 170 Artis zee floor units due to a power supply tolerance issue that may 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, but the hazard is a functional failure preventing imaging rather than a direct physical injury or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 170 units of the Artis zee floor, Model Number 10094135. The recall is due to a tolerance issue in the power supply of the generator control that may cause generator A100 failure. This failure prevents the X-ray tube from receiving the required voltage, making X-ray imaging impossible.
The issue occurs sporadically but may happen during an ongoing procedure. The affected units were distributed nationwide in the United States. Siemens Medical Solutions USA, Inc. is the recalling firm.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, the facility should contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Artis zee floor, Model Number 10094135
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 170
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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