Class 2 Device Recall GE Innova 2100IQ

• Date Initiated by Firm: October 09, 2008
• Date Posted: September 24, 2009
• Recall Status: Terminated on January 07, 2012
• Recall Number: Z-1687-2009
• Recall Event ID: 53260
• 510(K)Number: K052412 K061163
• Product Classification: Solid State X-Ray Imager - Product Code MQB
• Product: GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). ; ; Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
• Code Information: Serial Numbers: 00000549014BU9 00000559113BU6 00000468132BU6 00000550787BU6 00000476562BU4 00000504278BU3 00000541267BU1 00000504213BU0 00000543793BU4 00000471654BU4 00000493726BU4 00000484054BU2 00000480361BU5 00000491716BU7 00000480141BU1 00000478109BU2 00000551073BU0 00000542139BU1 00000548596BU6 00000568569BU8 00000492255BU5 00000548503BU2 00000545486BU3 00000552387BU3 00000485315BU6 00000558901BU5 00000466659BU0 00000470059BU7 00000466984BU2 00000572055BU2 00000505180BU0 00000499524BU7 00000473103BU0 00000544810BU5 00000566379BU4 00000566835BU5 00000499523BU9 00000500515BU0 00000571259BU1 00000472240BU1 00000499386BU1 00000559819BU8 00000551081BU3 00000484361BU1 00000564503BU1 00000549262BU4 00000551080BU5 00000520192BU6 00000490443BU9 00000476249BU8 00000461599BU3 00000533867BU8 00000537820BU3 00000054776BU4 00000548841BU6 00000543266BU1 00000551641BU4 00000512954BU9 00000493888BU2 00000518354BU6 00000553078BU1 00000469582BU1 00000545962BU3 00000485032BU7 00000566594BU8 00000468193BU8 00000570102BU4 00000569024BU3 00000545490BU5 00000543797BU5 00000509365BU3 00000560479BU8 00000479585BU2 00000548595BU8 00000543796BU7 00000531109BU7 00000552382BU4 00000460641BU4 00000460969BU9 00000550786BU8 00000504275BU9 00000493887BU4 00000563630BU3 00000552746BU0 00000563628BU7 00000531111BU3 00000569371BU8 00000513959BU7 00000466830BU7 00000473099BU0 00000479758BU5 00000479243BU8 00000477389BU1 00000500616BU8 00000509440BU4 00000566146BU7 00000491709BU2 00000543076BU4 00000546168BU6 00000561529BU9 00000509441BU2 00000491706BU8 00000562976BU1 00000553276BU7 00000477893BU2 00000546167BU8 00000560911BU0 00000515486BU9 00000537597BU7 00000564215BU2 00000538055BU5 00000493727BU2 00000562518BU1 00000508010BU6 00000559585BU5 00000560474BU9 00000552390BU7 00000483161BU6 00000559233BU2 00000479216BU4 00000465375BU4 00000483162BU4 000000006U0007 00000533870BU2 00000552055BU6 00000556787BU0 00000500612BU7 00000567993BU1 00000569026BU8 00000567352BU0 00000567338BU9 00000509439BU6 00000464559BU4 00000463841BU7 00000479937BU5 00000499840BU7 00000567334BU8 00000493725BU6 00000544289BU2 00000560909BU4 00000552385BU7 00000469466BU7 00000543169BU7 00000542273BU8 00000467455BU2 00000492106BU0 00000546157BU9 00000492922BU0 00000567350BU4 00000552386BU5 00000565106BU2 00000517924BU7 00000547292BU3 00000538034BU0 00000513294BU9 00000471760BU9 00000548165BU0 00000471487BU9 00000468168BU0 00000476109BU4 00000523240BU0 00000461379BU0 00000542138BU3 00000478363BU5 00000504277BU5 00000480315BU1 00000480140BU3 00000479701BU5 00000476013BU8 00000492457BU7 00000513296BU4 00000538053BU0 00000545052BU3 00000541271BU3 00000477463BU4 00000511494BU7 00000548592BU5 00000551634BU9 00000468192BU0 00000469465BU9 00000470060BU5 00000545048BU1 00000523777BU1 00000545046BU5 00000461266BU9 00000523086BU7 00000516769BU7 00000538572BU9 00000537027BU5 00000540176BU5 00000553269BU2 00000491032BU9 00000543265BU3 00000543798BU3 00000548598BU2 00000540174BU0 00000544495BU5 00000542274BU6 00000510844BU4 00000541966BU8 00000476725BU7 00000492136BU7 00000569021BU9 00000513958BU9 00000530413BU4 00000549261BU6 00000543799BU1 00000560472BU3 00000478275BU1 00000492243BU1 00000476685BU3 00000545588BU6 00000465560BU1 00000543269BU5 00000509136BU8 00000537449BU1 00000523241BU8 00000491172BU3 00000551444BU3 00000522942BU2 00000564216BU0 00000008C20126 00000565614BU5 00000563636BU0 00000551443BU5 and 00000545589BU4.
• Recalling Firm/ Manufacturer: Ge Healthcare; 9900 W Innovation Dr; Wauwatosa WI 53226-4856
• Manufacturer Reason for Recall: GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. This may result, when using large Equival
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.
• Quantity in Commerce: 929 units total
• Distribution: Nationwide Distribution -- United States including Puerto Rico and Guam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQB and Original Applicant = GE HEALTHCARE; 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC