Device Recall Artis Q

model numbers: 10848281; 10848354

Radiology Devices

2

No

Nationwide Distribution

Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Model Number of device:10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 with serial numbers: 109033 123026 121061 121089 121094 109080 109074 121006 121013 121040 109119 111005 109016 121062 109118 111002 121082 121011 121039 123008 109066 109067 109068 121053 121054 117001 117023 123003 123011 103030 109084 121014 121051 109011 109096 121004 117021 121018 121036 123013 123014 117029 117006 121012 121049 103013 109102 121078 109015 109009 121019 109057 121010 117034 109108 103008 109103 121081 109038 109040 109034 117020 105016 109029 121096 111003 123025 121015 109064 117018 117030 109058 121016 109050 109076 117026 123022 109007 103001 111000 109071 109072 109075 121020 109091 109090 109041 109039 109060 121047 123023 123024 117024 121088 109088 121027 103028 109092 109032 121009 121056 121057 109021 121034 121008 109048 109020 109036 109043 123027 109101 109104 109105 109107 121058 121085 109047 117040 109031 109027 109028 105017 109010 109093 121071 109069 117014 123010 117009 121023 123015 123016 121079 121041 109044 121037 121046 105007 121072

Radiology Devices

2

No

Nationwide

Artis Q/ Q zen systems; Artis Q/ Q zen systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Model Number of device: 10848282 10848281 10848355 10848354 serial numbers: 121006 121013 109016 121011 123008 123003 123011 121014 109011 121004 121018 121036 121012 109015 109009 121019 121010 121015 121016 109007 111000 121020 121009 121056 121057 109021 121008 109020 109027 109010 123010 121041

Radiology Devices

2

No

US Nationwide

Artis Q systems; || 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

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

Radiology Devices

2

No

US Nationwide Distribution.

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 body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

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

Radiology Devices

2

No

US Nationwide Distribution.

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 radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.