FDA-Device2018-08-22Class II
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is 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 family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, mul
Siemens Medical Solutions USA, Inc
Hazard
Potential hardware issue which may cause thermal effects and possible damage to system parts.
Sold states
US Nationwide Distribution
Affected count
605 units in total
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is 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 family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2747-2018Don't want to check this manually?
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