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U.S. Department of Health and Human Services

Class 2 Device Recall GE LightSpeed CT750 HD Computed Tomography Xray System

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 Class 2 Recall
GE LightSpeed CT750 HD Computed Tomography Xray System
see related information
Date Posted August 09, 2013
Recall Status1 Terminated on August 11, 2014
Recall Number Z-1940-2013
Recall Event ID 65333
Premarket Notification
510(K) Number
K081105 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.
Code Information GSI Viewer on CT750HD CT Systems  Software Update to 10MW25.6 Serial# 00000409809CN1 00000421170CN2 00000409525CN3 00000410002CN0 00000408483CN6 00000406075CN2 00000404225CN5 00000405725CN3 00000408128CN7 00000409481CN9 00000408280CN6 00000419816CN4 00000408127CN9 00000408230CN1 00000409450CN4 00000412501CN9 00000411125CN8 00000409344CN9 00000409145CN0 00000412398CN0 00000409881CN0 00000413835CN0 00000413765CN9 00000411126CN6 00000412015CN0 00000412399CN8 00000411349CN4 00000411611CN7 00000414853CN2 00000415105CN6 00000416839CN9 00000416410CN9 00000409806CN7 00000414686CN6 00000420612CN4 00000421374CN0 00000411613CN3 00000415502CN4 00000412042CN4 00000414971CN2 00000413841CN8 00000413362CN5 00000413566CN1 00000420173CN7 00000412503CN5 00000415396CN1 00000415826CN7 00000421147CN0 00000414851CN6 00000415104CN9 00000419891CN7 00000420174CN5 00000414852CN4 00000414973CN8 00000416765CN6 00000418112CN9 00000418335CN6 00000420610CN8 00000416669CN0 00000415439CN9 00000416628CN6 00000417737CN4 00000415469CN6 00000417465CN2 00000419582CN2 00000421590CN1 00000418155CN8 00000417172CN4 00000418484CN2 00000419819CN8 00000418156CN6 00000421378CN1 00000419107CN8 00000422266CN7 00000421121CN5 00000419817CN2 00000422267CN5 00000411391CN6 00000416872CN0 00000417476CN9 00000419135CN9 00000419447CN8 00000408673CN2 00000411348CN6 00000409754CN9 00000409805CN9 00000412738CN7 00000416033CN9 00000416779CN7 00000416974CN4 00000417373CN8 00000409751CN5 00000409343CN1 00000409755CN6 00000409807CN5 00000409753CN1 00000417769CN7 00000414972CN0 00000415092CN6 00000414879CN7 00000416546CN0 00000416122CN0 00000416037CN0 00000419954CN3 00000418659CN9 00000416943CN9 00000417766CN3 00000409879CN4 00000415358CN1 00000413323CN7 00000415204CN7 00000415203CN9 00000417806CN7 00000415448CN0 00000415240CN1 00000414058CN8 00000417618CN6 00000416588CN2 00000416366CN3 00000416545CN2 00000417422CN3 00000418021CN2 00000418154CN1 00000418033CN7 00000421065CN4 00000419773CN7 00000419732CN3 00000417222CN7 00000421290CN8 00000419890CN9 00000409160CN9 00000416309CN3 00000416034CN7 00000420866CN6 00000414878CN9 00000418469CN3 00000409575CN8 00000409880CN2 00000409877CN8 00000411339CN5 00000413307CN0 00000414106CN5 00000412737CN9 00000414912CN6 00000416121CN2 00000409808CN3 00000416766CN4 00000417736CN6 00000418032CN9 00000418822CN3 00000418002CN2 00000417871CN1 00000420868CN2 00000420387CN3 00000421730CN3 00000412739CN5 00000412804CN7 00000414854CN0 00000417329CN0 00000417645CN9 00000412502CN7 00000405726CN1 00000416788CN8 00000409878CN6 00000418304CN2 00000407781CN4 00000418983CN3 00000419136CN7 00000411639CN8 00000414788CN0 00000414748CN4 00000413967CN1 00000416375CN4 00000419703CN4 00000409159CN1 00000407937CN2 00000411566CN3 00000413324CN5 00000409451CN2 00000414582CN7 00000415411CN8 00000409408CN2 00000414657CN7 00000415835CN8 00000415387CN0 00000416522CN1 00000416619CN5 00000416871CN2 00000417087CN4 00000417330CN8 00000417765CN5 00000416978CN5 00000418279CN6 00000418176CN4 00000417755CN6 00000418524CN5 00000419777CN8 00000421146CN2 00000421066CN2 00000421232CN0 00000421233CN8 00000421291CN6 00000421148CN8 00000421231CN2 00000421377CN3 00000418700CN1 00000415447CN2 00000417178CN1 00000418149CN1 00000418523CN7 00000420611CN6 00000414057CN0 00000416243CN4 00000420588CN6 00000421063CN9 00000417768CN9 00000411825CN3 00000408320CN0 00000413092CN8 00000417251CN6 00000419133CN4 00000419132CN6 00000421171CN0 00000420613CN2 00000409621CN0 00000415872CN1 00000416032CN1 00000416446CN3 00000418830CN6 00000419704CN2 00000414317CN8 00000418177CN2 00000408437CN2 00000409752CN3 00000414094CN3 00000415957CN0 00000414874CN8 00000416787CN0 00000417487CN6 00000418331CN5 00000420590CN2 00000420426CN9 00000420383CN2 00000420589CN4
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does no
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare's recall strategy was to update CT750HD CT Systems with software 10MW25.6 on all systems that were distributed. Updates started on 4/5/2011. At this time, deployment of this recall is considered complete. The recall was completed 2/2/2012. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2198 or email paulcorrigan@ge.com.
Quantity in Commerce 244
Distribution Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT, FL, GA, HI, IL, IN, IA, KY,ME, MD,MA, MI,MN, MS, NV, NH, NJ, NY, NC, PA, TN, TX, VA, WA,WV, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANDA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, NEW ZEALAND, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUKEY, and 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
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