Siemens Artis zee/zeego Systems Recalled for X-Ray Tube Focal Spot Failure
Siemens Medical Solutions is recalling 44 Artis zee/zeego angiography systems because the small focus of the x-ray tube may fail, causing a short interruption in procedures.
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, but the hazard involves a functional interruption requiring manual switchover rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 44 Artis zee/zeego dedicated angiography systems. The affected model numbers are 10094135, 10094137, 10094139, 10094141, and 10280959. These systems are used for single and biplane diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.
The recall is due to a potential failure of the small focus of the 3 focal spot x-ray tube. If this failure occurs, the release of radiation from that specific focal spot will not be possible. The Large Focus and Micro Focus focal spots will remain operational without restriction. However, a manual switchover is required to continue the procedure, which results in a short interruption.
The affected units were distributed in the United States to the states of MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, OH, PA, and CO. Specific serial numbers for the 44 units are listed in the official recall documentation. Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address the issue.
The recalled product
- Product
- Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures tha
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 44
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)
- model numbers: 10094135
- 10094137
- 10094139
- 10094141
- 10280959
Distribution
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