Siemens Medical Solutions USA, Inc: The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

Agency Publication Date: November 17, 2016

Affected Products

Product: Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radio

Model Numbers: 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355

Product: Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole bo

Model Numbers: 10094135, 10094137, 10094139, 10094141, 10280959

Product: AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body

Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75606

Status: Resolved

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 3 products (4,657 systems (worldwide); 4,657 systems Worldwide; 4,657 systems Worldwide)

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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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Affected Products

Model Numbers: 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355

Model Numbers: 10094135, 10094137, 10094139, 10094141, 10280959

Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392