[Recalled] 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. — There is a potential issue on running Artis systems run
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Siemens Medical Solutions USA, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0486-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 September 2013 |
| EAN / barcode | 10094135 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.