medical Class II Updated 2023-08-16

Siemens Medical Solutions USA, Inc recalls ARTIS pheno-Angiography systems developed for single and bip

Recalled Product

ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000


Hazard / Issue

Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 4056869149325 Serial Numbers: Serial 164840 164851 164854 164853 164855 164856 164833 164836 164845 164850
View official government recall

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