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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 3100IQ (Optima Edition) Fluoroscopic Vascular Xray System

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 Class 2 Recall
Innova 3100IQ (Optima Edition) Fluoroscopic Vascular Xray System
see related information
Date Posted October 28, 2011
Recall Status1 Terminated on May 29, 2012
Recall Number Z-0133-2012
Recall Event ID 59521
Premarket Notification
510(K) Numbers
K042053  K052157  K052412  K061163  K092004  K092639 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product GE Healthcare, Innova® 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging-procedures.
Code Information 00000002010011 599032BU0 00000002011001 00000002011002 598347BU3 00000002010013 00000002010017 00000002010012 00000002010014 00000002010015 599038BU7 00000002010016 00000002010010 00000002011003 00000002010007
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
A potential weakness on the monitor suspension end-stop device may impact user safety. The end-stops may break if the monitor-suspension is repeatedly pushed with excessive force on the end rails.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action A GE Healthcare "Urgent Medical Device Correction" letter dated August 22, 2011 was sent out 8/24/11. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Users were told to operate the suspension without excessive force. If one of the end-stops breaks, then the system should not be used and their local GE Healthcare Service Representative should be contacted. GE will contact customers to replace all end-stops at no cost to the customer. Questions or concerns should be directed to 800-437-1171 in the US and 0120-055-919 in Japan. For other countries, customers can contact their local GE Healthcare Service Representative.
Quantity in Commerce 15
Distribution Worldwide Distribution -- USA, including the states of TX & NC and the countries of TURKEY, POLAND, MEXICO, CHINA, CAMBODIA, BRAZIL, BOLIVIA, and SAUDI ARABIA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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 SCS
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
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