Siemens Medical Solutions USA, Inc: 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

Agency Publication Date: August 8, 2023

Affected Products

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

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

Product: ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700

UDI-DI: 4056869149325 Serial Numbers: 170561 170549 170559 170546 170552 170571 170570

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

UDI-DI: 4056869149325 Serial Numbers: Serial 164840 164851 164854 164853 164855 164856 164833 164836 164845 164850

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92653

Status: Active

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 3 products (14 units; 7 units; 10 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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