| ||Class 2 Recall|
Digital Fluoroscopic Imaging System
||May 19, 2009
|Recall Event ID
Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
||Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.
||Product Number: 2121-IQ; Serial Numbers:
Product Number: 3131-IQ; Serial Numbers:
|GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
|GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure.
|DESIGN: Device Design
||A GE Healthcare "Urgent Medical Device Correction" letter dated February 2, 2009 was sent to consignees via mail. The letter was directed to Hospital Administrator/Risk Manger, Managers of Radiology/Cardiology and Radiologists/Cardiologists addressing the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Further questions should be addressed to GE Healthcare at 1-800-437-1171.
|Quantity in Commerce
||Worldwide Distribution -- USA including states of CA, CO, FL, HI, IA, IL, IN, KS, MD, MA, MN, MO, NY, OH, OR, PA, TN, TX, WA, WV, WI and VA and countries of the United Kingdom, Romania, Japan, Taiwan, Bahrain, France, Malaysia, India, Canada, Chile, Indonesia, Ireland and Italy.
|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 MEDICAL SYSTEMS, LLC