Siemens Artis zee/zeego Angiographic X-ray System Recall for Generator Defects
Siemens is recalling Artis zee/zeego angiographic x-ray systems due to potential high-voltage generator failures and rare image display loss.
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, which typically corresponds to a Moderate severity score (2) in the absence of reported hospitalizations or significant injuries, as the defects are described as potential or rare.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling approximately 1,500 Artis zee/zeego angiographic x-ray systems distributed worldwide. The recall addresses two independent system defects: a potential failure of a module in the high-voltage generator when attempting to resume operation after a fault, and rare instances of image display loss in the examination room for biplane systems with specific software versions.
The high-voltage generator issue affects Artis Systems equipped with A100 Plus or A100G generators. The image display issue affects biplane systems delivered with software version VD11B since April of the recall year, where software problems in conjunction with the graphics card may cause the display to fail. The affected model numbers are 10094135, 10094137, 10094139, 10094141, 10280959, and 10848283.
Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. to arrange for corrective action. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedure
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1,500
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 # 10094135
- 10094137
- 10094139
- 10094141
- 10280959
- 10848283
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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