Class 2 Device Recall GE Innova 3100

• Date Initiated by Firm: October 09, 2008
• Date Posted: September 24, 2009
• Recall Status: Terminated on January 07, 2012
• Recall Number: Z-1688-2009
• Recall Event ID: 53260
• 510(K)Number: K052412 K031637 K061163
• Product Classification: Solid State X-Ray Imager - Product Code MQB
• Product: GE Innova 3100, Cardiovascular 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: 00000529517BU5 00000458534BU5 00000435031BU0 00000566382BU8 00000512956BU4 00000550134BU1 00000549706BU0 00000523132BU9 00000537463BU2 00000547770BU8 00000446090BU3 00000491058BU4 00000537465BU7 00000476260BU5 00000530412BU6 00000555080BU1 00000437215BU7 00000465048BU7 00000482707BU7 00000541969BU2 00000488003BU5 00000545420BU2 00000556280BU6 00000484393BU4 00000544285BU0 00000523134BU5 00000477394BU1 00000482419BU9 00000551636BU4 00000509132BU7 00000568027BU7 00000543272BU9 00000545590BU2 00000548338BU3 00000482661BU6 00000440229BU3 00000521654BU4 00000544808BU9 00000565460BU3 00000520189BU2 00000512758BU4 00000509817BU3 00000545421BU0 00000482188BU0 00000477767BU8 00000557461BU1 00000445301BU5 00000543795BU9 00000424103BU0 00000545419BU4 00000454181BU9 00000449819BU2 00000463520BU7 00000552743BU7 00000548601BU4 00000442172BU3 00451726BU4BU8 00000497601BU5 00000438668BU6 00000492274BU6 00000505219BU6 00000567995BU6 00000571256BU7 00000465766BU4 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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; 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC