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    AXIOM Artis dTC, Model Number 7413078

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021

    AXIOM Artis dTC, Model Number 7413078

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·September 2, 2008

    AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·August 25, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-965.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-966.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip extension module BB7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-204. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-203. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-651-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-042. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral neck Y, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-746-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral neck B-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-686-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-012. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip extension module YY7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-006. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-052. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-072. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-021. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-031. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008

    Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-652-000. Product is used for Orthopedic surgery.

    FDA Recall
    Terminated ·Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia·Product code MEH·January 11, 2008