| ||Class 2 Recall|
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ
||April 18, 2013
||Terminated on February 04, 2014
|Recall Event ID
Interventional Fluoroscopic X-Ray System - Product Code OWB
||GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ,
Cardiovascular and Interventional Imaging System.
|GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
|As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the
Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co
|DESIGN: Labeling Design
||A field action was initiated on October 21, 2011, and completed March 9, 2012, . The issue was corrected to all affected systems by applying the missing label onto the gantry. No recall letter was issued.
For further questions please call (262) 513-4122.
|Quantity in Commerce
||Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia.
|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 = OWB and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = OWB and Original Applicant = GE MEDICAL SYSTEMS, INC.
510(K)s with Product Code = OWB and Original Applicant = GE MEDICAL SYSTEMS, LLC