medical Class II Updated 2023-08-16

Siemens Medical Solutions USA, Inc recalls ARTIS icono biplane -Angiography systems developed for singl

Recalled Product

ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600


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: 4056869063317 Serial Numbers: 180550 180517 180518 180546 180547 180560 180534 180556 180537 180545 180533 180566 180536 180563
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