Siemens Artis zee Ceiling Recalled for Power Supply Tolerance Issue
Siemens Medical Solutions is recalling 428 Artis zee ceiling units due to a power supply tolerance issue that may cause generator failure and prevent X-ray production.
What this means for you
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 is a functional failure preventing X-ray use, which is a significant operational issue but does not involve direct physical injury, death, or serious health consequences as defined in the rubric for higher severities.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 428 units of the Artis zee ceiling, Model Number 10094137. The recall is due to a tolerance issue in the power supply of the generator control that may cause generator A100 failure. This failure results in the X-ray tube not 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. The recall number is Z-2029-2019.
Hospitals and medical facilities should check their inventory for the specific serial numbers listed in the recall notice. Siemens Medical Solutions is the recalling firm responsible for addressing this defect.
The recalled product
- Product
- Artis zee ceiling, Model Number 10094137
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 428
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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