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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 Device Recall GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ see related information
Date Initiated by Firm February 04, 2011
Date Posting Updated March 11, 2013
Recall Status1 Terminated 3 on January 27, 2014
Recall Number Z-0934-2013
Recall Event ID 64274
510(K)Number 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





























































































































































































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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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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