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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 Device 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
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#
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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
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
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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