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U.S. Department of Health and Human Services

Class 2 Device Recall GE LightSpeed VCT

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 Class 2 Device Recall GE LightSpeed VCTsee related information
Date Initiated by FirmSeptember 03, 2010
Date PostedNovember 15, 2010
Recall Status1 Terminated 3 on May 15, 2012
Recall NumberZ-0368-2011
Recall Event ID 56814
510(K)NumberK052855 K082761 K082816 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductGE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 USA. 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, and Gated acquisitions.
Code Information Model 5212920-300, serial numbers: 00000021775YC2. 00000408285CN5. 00000409136CN9. 00000412029CN1. 00000412391CN5. 00000414803CN7. 00000415599CN0. 00000416813CN4. 00000417885CN1.   Model 5212920-310, serial numbers: 00000416740CN9. 00000417311CN8. 00000417519CN6. 00000417884CN4. 00000417886CN9. 00000417916CN4. 00000417917CN2. 00000417918CN0. 00000417919CN8. 00000417925CN5. 00000417926CN3. 00000417989CN1. 00000417990CN9. 00000418000CN6. 00000418055CN0. 00000418056CN8. 00000418057CN6. 00000418058CN4. 00000418059CN2. 00000418060CN0. 00000418062CN6. 00000418063CN4. 00000418064CN2. 00000418065CN9. 00000418126CN9. 00000418141CN8. 00000418142CN6. 00000418179CN8. 00000418218CN4. 00000418219CN2. 00000418220CN0. 00000418221CN8. 00000418222CN6. 00000418246CN5. 00000418260CN6. 00000418261CN4. 00000418266CN3. 00000418272CN1. 00000418293CN7. 00000418296CN0. 00000418337CN2. 00000418355CN4. 00000418365CN3. 00000418400CN8. 00000418404CN0. 00000418467CN7. 00000418541CN9. 00000418542CN7. 00000418581CN5. 00000418586CN4. 00000418604CN5. 00000418706CN8. 00000418717CN5. 00000418789CN4. 00000418790CN2. 00000418793CN6.   Model 5311595-10, serial numbers: 00000031546CO5. 00000031835CO2. 00000031838CO6. 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactCall Center
800-437-1171
Manufacturer Reason
for Recall		GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.
FDA Determined
Cause 2		Software design
ActionAn Urgent Medical Device Correction letter dated September 2, 2010 was sent to consignees beginning September 3, 2010. This letter addressed the LightSpeed VCT systems. Another Urgent Medical Device Correction letter, dated September 24, 2010 was sent September 24, 2010 for the BrightSpeed Systems. The letters described the issue and provided safety instructions for the health care provider to be aware if the table should stop unexpectedly and the x-ray remains on to manually stop the scan until the devices software is upgraded. If you have any questions, please contact the US (800) 437-1171, Japan 0120-055-919, Korea 1544-6119, Australia/New Zealand 800 659 465, China 800-810-8188; for other countries, please contact your local GE Healthcare Services Representative.
Quantity in Commerce68
DistributionWorldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Ireland, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Kenya, Lebanon, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
510(K)s with Product Code = JAK
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