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U.S. Department of Health and Human Services

Class 2 Device Recall GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT7

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 Class 2 Recall
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT7
see related information
Date Posted April 29, 2013
Recall Status1 Terminated on February 04, 2014
Recall Number Z-1188-2013
Recall Event ID 64889
Premarket Notification
510(K) Numbers
K013561  K030420  K040372  K081105  K081496 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Code Information Serial Number 00000416307CN7 00000416534CN6 00000418451CN1 00000416467CN9 00000414273CN3 00000416594CN0 00000416589CN0 00000416532CN0 00000417617CN8 00000416889CN4 00000416685CN6 00000418151CN7 00000416332CN5 00000416591CN6 00000416468CN7 00000416333CN3 00000419445CN2 00000416269CN9 00000416815CN9 00000416117CN0 00000416524CN7 00000416267CN3 00000419240CN7 00000416646CN8 00000417864CN6 00000416195CN6 00000419505CN3 00000418001CN4 00000416816CN7 00000416551CN0 00000416201CN2 00000417625CN1 00000417650CN9 00000416220CN2 00000419411CN4 00000416390CN3 00000418913CN0 00000416737CN5 00000416738CN3 00000416777CN1 00000416363CN0 00000416888CN6 00000416590CN8 00000417177CN3 00000419041CN9 00000416850CN6 00000416627CN8 00000417275CN5 00000417709CN3 00000417133CN6 00000419446CN0 00000419375CN1 00000418807CN4 00000418035CN2 00000418238CN2 00000418843CN9 00000417786CN1 00000419393CN4 00000417695CN4 00000419507CN9 00000419078CN1 00000419280CN3 00000419390CN0 00000419526CN9 00000419525CN1 00000419559CN0 00000418819CN9 00000419506CN1 00000418402CN4 00000419089CN8 00000419550CN9 00000416736CN7 00000418656CN5 00000416781CN3 00000416798CN7 00000418357CN0 00000419447CN8 00000416552CN8 00000418810CN8 00000416764CN9 00000419178CN9 00000417719CN2 00000416389CN5 00000418514CN6 00000417634CN3 00000416848CN0 00000417733CN3 00000417716CN8 00000416849CN8 00000417649CN1 00000416286CN3 00000416401CN8 00000418847CN0 00000419177CN1 00000416533CN8 00000417644CN2 00000419376CN9 00000419504CN6 00000416231CN9 00000416301CN0 00000417626CN9 00000418403CN2 00000419079CN9 00000416268CN1 00000416620CN3 00000416597CN3 00000416763CN1 00000418780CN3 00000417643CN4 00000416647CN6 00000417642CN6 00000418791CN0 00000416466CN1 00000416388CN7 00000416353CN1 00000417134CN4 00000419241CN5 00000418915CN5 00000419174CN8 00000418818CN1 00000416295CN4 00000417720CN0 00000418846CN2 00000416372CN1 00000416762CN3 00000417714CN3 00000416882CN9 00000417713CN5 00000417725CN9 00000416595CN7 00000418020CN4 00000417734CN1 00000419448CN6 00000417735CN8 00000417787CN9 00000419054CN2 00000417696CN2 00000418932CN0 00000419173CN0 00000418300CN0 00000417717CN6 00000418845CN4 00000419561CN6 00000418696CN1 00000418848CN8 00000366477CN8 00000220652HM2 00000421152CN0 00000419040CN1 00000418844CN7 00000416202CN0 00000419391CN8 00000416371CN3 00000418781CN1 00000416814CN2 00000416593CN2 00000416200CN4 00000416739CN1 00000416465CN3 00000416670CN8 00000416881CN1 00000416525CN4 00000416284CN8 00000416796CN1 00000418943CN7 00000419039CN3
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspe
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action No consignee letter was sent out. At customer site Field Engineer replaced heat exchanger, the tube and the pump. Field Engineer also verified torque on all bolts. Field action was initiated on 7/25/2011 and has been completed as of 3/29/2013.
Quantity in Commerce 166
Distribution Worldwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CO, CT, FL,GA, IL, IN, KY, MA, MI, MS,MO, NH, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TX, UT, VA, WA, and WI and the countries of ALBANIA ARGENTINA AUSTRALIA BELGIUM BRAZIL CANADA CHINA COLOMBIA COSTA RICA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GREECE HONG KONG HUNGARY INDIA IRELAND ITALY JAPAN KOREA, REPUBLIC OF MEXICO MOROCCO NIGERIA NORWAY POLAND RUSSIAN FEDERATION SINGAPORE SPAIN SWEDEN SWITZERLAND TURKEY UKRAINE UNITED KINGDOM.
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 = JAK and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = JAK and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
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