Siemens Artis zee Angiography System Software Recall
Siemens is recalling 1,131 Artis zee and zeego Angiography Systems due to a software issue that prevents deactivating the radiation block function after a network problem.
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 source text describes a functional limitation (inability to deactivate a block function) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor operational defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,131 units of the Artis zee and zeego Angiography Systems. The recall involves specific model numbers and serial numbers distributed worldwide, including the United States and numerous international locations.
The recall is due to a potential issue with the VC1x software. If a network problem occurs, the "Block Radiation" function may not be deactivated by pressing the key on the touch screen control. In this scenario, the system's image generation function is unavailable for patient examinations unless the system is manually switched off and back on.
Healthcare facilities using these systems should verify their equipment against the provided model and serial number lists. Siemens is addressing the issue to ensure the radiation block function can be properly managed during network interruptions.
The recalled product
- Product
- The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1,131
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 (6)
- model numbers: 10094135
- 10094137
- 10094139
- 10094141
- 10094142
- 10094143
Distribution
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