ARTIS Pheno 3D acquisitions may capture uneven patient image brightness
ARTIS Pheno VE30A and VE40A systems are being recalled because 3D acquisitions may capture lighter and darker images, reducing reconstruction accuracy. 73 units are affected.
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: FDA Class II recall affecting 3D reconstruction accuracy and patient radiation exposure, a risk of harm with no injuries reported in the source.
Plain-English summary
ARTIS Pheno VE30A and VE40A interventional imaging systems, model 10849000, UDI 04056869046877, are being recalled. The action covers 73 units.
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. According to the manufacturer, the variation in brightness results from a constant unregulated medium dose combined with the angular change of patient diameter during rotational acquisition, and this may result in unintentional low-dose radiation exposure to a patient. The FDA classified the action as Class II.
Distribution was in the United States and internationally. The systems are installed in hospital interventional suites rather than sold to consumers.
Facilities should identify affected systems using the model number and UDI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- ARTIS Pheno VE30A and VE40A, Model 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 73
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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