Siemens Artis zee Angiographic X-ray System Software Recall
Siemens is recalling three Artis zee angiographic x-ray systems due to a software fault that prevents the system from initializing after a tube assembly failure.
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 FDA classified this as a Class II recall, and the source text does not report any injuries, illnesses, or deaths. The hazard is a functional software failure rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three units of the Artis zee angiographic x-ray system. The recall involves specific device model numbers 10280959, 10094137, and 10094141, with serial numbers 160449, 147208, and 153744. These units were distributed to facilities in Virginia, California, and Wisconsin.
The recall is due to a software fault in systems running software version VD11 with an A100 generator. If a tube assembly focus fails, the system may continue to function until the next reactivation. However, following reactivation, the system fails to initialize as intended.
The FDA has classified this as a Class II recall. No injuries or illnesses have been reported in connection with this defect. Affected facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the software issue.
The recalled product
- Product
- Artis zee, Angiographic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Device Model Numbers: 10280959
- 10094137
- 10094141
- Serial numbers: 160449 147208
- 153744
Distribution
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