| ||Class 2 Recall|
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ
||March 11, 2013
Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
||GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging
For use in generating fluoroscopic images of human anatomy.
|GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
|Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
||No consignee letter sent out. GE Healthcare's recall strategy was to replace the impacted cable on all affected Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ systems that were distributed. At this time, deployment of this recall is considered complete as of 9/6/2011.
|Quantity in Commerce
||Worldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL.
|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.