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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ

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 Class 2 Recall
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ
see related information
Date Posted March 11, 2013
Recall Status1 Terminated on January 27, 2014
Recall Number Z-0934-2013
Recall Event ID 64274
Premarket Notification
510(K) Numbers
K050489  K052412  K061163  K092004 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
Code Information SERIAL NUMBER 592043BU4 592676BU1 593459BU1 593465BU8 592458BU4 592673BU8 592682BU9 593059BU9 593051BU6 593475BU7 593476BU5 592049BU1 593468BU2 593054BU0 592047BU5 592042BU6 592046BU7 592459BU2 593048BU2 593056BU5 593049BU0 593063BU1 593062BU3 593464BU1 594762BU7 593473BU2 592451BU9 593460BU9 597954BU7 592456BU8 592674BU6 593052BU4 593058BU1 590867BU8 592050BU9 593064BU9 592460BU0 592457BU6 592680BU3 592455BU0 593462BU5 592678BU7 594763BU5 593055BU7 592675BU3 592452BU7 593463BU3 594385BU7
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action 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 48
Distribution 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.
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, LLC
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