[pending] ARTIS Pheno VE30A and VE40A, Model 10849000
Pending LLM rewrite. Source: FDA_DEVICE Z-1814-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
The recalled product
- Product
- ARTIS Pheno VE30A and VE40A, Model 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Devices
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 (1)
- UDI 04056869046877
Distribution
Distribution scope not specified by the agency.
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