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U.S. Department of Health and Human Services

Class 2 Device Recall GE Innova 3100IQ

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  Class 2 Device Recall GE Innova 3100IQ see related information
Date Initiated by Firm October 09, 2008
Date Posted September 24, 2009
Recall Status1 Terminated 3 on January 07, 2012
Recall Number Z-1689-2009
Recall Event ID 53260
510(K)Number K052412  K031637  K061163  
Product Classification Solid State X-Ray Imager - Product Code MQB
Product GE Innova 3100-IQ, 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 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and 00000563637BU8. 
Recalling Firm/
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 2
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