Class 2 Device Recall GE Innova 4100

• Date Initiated by Firm: October 09, 2008
• Date Posted: September 24, 2009
• Recall Status: Terminated on January 07, 2012
• Recall Number: Z-1690-2009
• Recall Event ID: 53260
• 510(K)Number: K052412 K023178 K061163
• Product Classification: Solid State X-Ray Imager - Product Code MQB
• Product: GE Innova 4100, 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: 00000486055BU7 00000470682BU6 00000452644BU8 00000569022BU7 00000485314BU9 00000560473BU1 00000567345BU4 00000567343BU9 00000436341BU2 00000420851BU8 00000416960BU3 00000562417BU6 00000569374BU2 00000479929BU2 00000476623BU4 00000444365BU3 00000468194BU6 00000567994BU9 00000442706BU8 00000431433BU2 00000520407BU8 00000556127BU9 00000568032BU7 00000043751BU3 00000438338BU6 00000441169BU0 00000432631BU0 00000510846BU9 00000563629BU5 00000454700BU6 00000423362BU3 00000458514BU7 00000534727BU3 00000477896BU5 00000441137BU7 00000476261BU3 00000470681BU8 00000541065BU9 00000523133BU7 00000553597BU6 00000439213BU0 00000447876BU4 00000542136BU7 00000419171BU4 00000558898BU3 00000543121BU8 00000562972BU0 00000538056BU3 00000560914BU4 00000437342BU9 00000556508BU0 00000544811BU3 00000552740BU3 00000408040BU4 00000563631BU1 00000411137BU3 00000549015BU6 00000437304BU9 00000465557BU7 00000545044BU0 00000421391BU4 00000438667BU8 00000492456BU9 00000560476BU4 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• 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, INC.; 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC