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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 Posted March 11, 2013
Recall Status1 Terminated 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






























































































































































































Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
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 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.
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