Fluoroscopic X-Ray System Recalled for Limited Movement After Startup
Siemens is recalling 20 Artis Pheno fluoroscopic X-ray systems due to limited movement after startup. The issue affects specific serial numbers across multiple US states.
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: FDA Class II medical device recall with no reported injuries, hospitalizations, or deaths. The issue is a functional limitation affecting equipment positioning, consistent with a voluntary precautionary recall rather than a safety hazard with demonstrated harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Artis Pheno Image-Intensified Fluoroscopic X-Ray System. This recall affects 20 units with specific model and serial numbers distributed to medical facilities across the United States.
The recalled systems experience limited movement after startup, which affects the system's positioning capability during imaging procedures.
The recall involves facilities in Alabama, Arizona, Florida, Kentucky, Massachusetts, Michigan, New York, Oregon, Pennsylvania, Tennessee, Texas, and Utah that operate the affected equipment. The specific serial numbers are identified in the FDA recall notice.
Customers should contact Siemens Medical Solutions USA, Inc. to determine appropriate next steps for the affected equipment.
The recalled product
- Product
- Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- positioning-failure
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 (20)
- Model No. 10849000
- UDI: 04056869046877
- Serial No. 164184
- 164183
- 164071
- 164072
- 164027
- 164026
- 164094
- 164019
- 164161
- 164152
- 164069
- 164086
- 164084
- 164158
- 164188
- 164105
- 164080
- 164011
Distribution
Distributed nationwide across the United States.
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