||October 28, 2011
||Terminated on May 29, 2012
|Recall Event ID
Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
||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.
|GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
|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.
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
||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
||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)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