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U.S. Department of Health and Human Services

Class 2 Device Recall GE BrightSpeed CT

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 Class 2 Recall
GE BrightSpeed CT
see related information
Date Posted November 15, 2010
Recall Status1 Terminated on May 15, 2012
Recall Number Z-0369-2011
Recall Event ID 56814
Premarket Notification
510(K) Numbers
K052855  K082761  K082816 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. 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. 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 2377708-560, serial numbers: 00000018952YC2. 00000018953YC0. 00000018954YC8. 00000019505YC7. 00000019506YC5. 00000019507YC3. 00000019508YC1. 00000019509YC9. 00000019663YC4. 00000019664YC2. 00000019665YC9. 00000019772YC3. 00000019773YC1. 00000019898YC6. 00000019899YC4. 00000020095YC6. 00000020147YC5. 00000020277YC0. 00000020278YC8. 00000020708YC4. 00000020709YC2. 00000020710YC0. 00000020835YC5. 00000020888YC4. 00000020936YC1. 00000020937YC9. 00000021104YC5. 00000021105YC2. 00000021106YC0. 00000021286YC0. 00000021287YC8. 00000021288YC6. 00000021289YC4. 00000021485YC8. 00000021486YC6. 00000021487YC4. 00000021488YC2. 00000021638YC2. 00000021639YC0. 00000021640YC8. 00000021850YC3. 00000021851YC1. 00000021966YC7. 00000021967YC5. 00000021975YC8. 00000021976YC6. 00000022244YC8. 00000022245YC5. 00000023063YC1. 00000023602YC6. 00000023981YC4. 00000024234YC7. 00000024374YC1. 00000025318YC7. 00000208246HM9. 00000210066HM7. 00000210067HM5. 00000210068HM3. 00000210069HM1. 00000210070HM9. 00000210348HM9. 00000210349HM7. 00000210350HM5. 00000211354HM6. 00000211450HM2. 00000211451HM0. 00000212790HM0. 00000212791HM8. 00000212792HM6. 00000212793HM4. 00000214155HM4. 00000214156HM2. 00000214408HM7. 00000214769HM2. 00000214770HM0. 00000214771HM8. 00000214772HM6. 00000214903HM7. 00000215052HM2. 00000215053HM0. 00000215054HM8. 00000215055HM5. 00000215056HM3. 00000215057HM1. 00000215349HM2. 00000215476HM3. 00000215477HM1. 00000215478HM9. 00000215479HM7. 00000216172HM7. 00000216173HM5. 00000216174HM3. 00000216175HM0. 00000216536HM3. 00000216537HM1. 00000217051HM2. 00000217052HM0. 00000217053HM8. 00000217391HM2. 00000217392HM0. 00000217591HM7. 00000217592HM5. 00000217593HM3. 00000217796HM2. 00000217797HM0. 00000218234HM3. 00000218235HM0. 00000218236HM8. 00000218421HM6. 00000218422HM4. 00000218423HM2. 00000218424HM0. 00000218425HM7. 00000218732HM6. 00000218733HM4. 00000219586HM5. 00000219587HM3. 00000219588HM1. 00000219589HM9. 00000219590HM7. 00000219702HM8. 00000219703HM6. 00000219704HM4. 00000220155HM6. 00000220156HM4. 00000220157HM2. 00000220158HM0. 00000220159HM8. 00000220512HM8. 00000220513HM6. 00000220514HM4. 00000220515HM1. 00000221055HM7. 00000221056HM5. 00000221057HM3. 00000221058HM1. 00000221059HM9. 00000221060HM7. 00000221681HM0. 00000221710HM7. 00000221711HM5. 00000221712HM3. 00000221713HM1. 00000221714HM9. 00000222284HM2. 00000222285HM9. 00000222286HM7. 00000222287HM5. 00000222288HM3. 00000222289HM1. 00000222784HM1. 00000222785HM8. 00000222786HM6. 00000222787HM4. 00000222788HM2. 00000222789HM0. 00000222790HM8. 00000222791HM6. 00000223455HM7. 00000223456HM5. 00000223534HM9. 00000223535HM6. 00000223536HM4. 00000223537HM2. 00000223538HM0. 00000223539HM8. 00000223540HM6. 00000223541HM4. 00000223542HM2. 00000223543HM0. 00000223900HM2. 00000223901HM0. 00000223902HM8. 00000223903HM6. 00000223904HM4. 00000224529HM8. 00000224530HM6. 00000224531HM4. 00000224541HM3. 00000224967HM0. 00000225116HM3. 00000225117HM1. 00000225118HM9. 00000225276HM5. 00000225277HM3. 00000225278HM1. 00000225279HM9. 00000225280HM7. 00000225839HM0. 00000225840HM8. 00000225841HM6. 00000225842HM4. 00000226232HM7. 00000226233HM5. 00000226234HM3. 00000226235HM0. 00000226236HM8. 00000226840HM7. 00000226841HM5. 00000226842HM3. 00000226843HM1. 00000227337HM3. 00000227338HM1. 00000227339HM9. 00000227340HM7. 00000227934HM7. 00000227935HM4. 00000227936HM2. 00000227937HM0. 00000227938HM8. 00000230075HM4. 00000230076HM2. 00000230077HM0. 00000231039HM9. 00000231040HM7. 00000231049HM8. 00000231498HM7. 00000231499HM5. 00000231500HM0. 00000231501HM8. 00000231654HM5. 00000234977HM7. 00000235478HM5. 00000236624HM3. 00000236689HM6. 00000236914HM8. 00000237109HM4. 00000237608HM5. 00000237609HM3. 00000237610HM1. 00000237611HM9. 00000239250HM4. 00000239251HM2. 00000239252HM0. 00000241506HM5. 00000241620HM4. 00000242448HM9. 00000242449HM7. 00000243034HM6. 00000243945HM3. 00000244390HM1. 00000244391HM9. 00000244392HM7. 00000245923HM8. 00000245924HM6. Model 5377708-540, serial numbers: 00000017325YC2. 00000017326YC0. 00000017327YC8. 00000017470YC6. 00000017471YC4. 00000017507YC5. 00000017508YC3. 00000017509YC1. 00000017510YC9. 00000017511YC7. 00000017512YC5. 00000017621YC4. 00000017665YC1. 00000017666YC9. 00000017821YC0. 00000017822YC8. 00000017823YC6. 00000017824YC4. 00000017825YC1. 00000017826YC9. 00000017827YC7. 00000018175YC0. 00000018181YC8. 00000018182YC6. 00000018183YC4. 00000018217YC0. 00000018218YC8. 00000018298YC0. 00000018299YC8. 00000018300YC4. 00000018403YC6. 00000018404YC4. 00000018511YC6. 00000018512YC4. 00000018513YC2. 00000018601YC5. 00000018602YC3. 00000018695YC7. 00000018696YC5. 00000018697YC3. 00000018698YC1. 00000018784YC9. 00000018785YC6. 00000018786YC4. 00000018900YC1. 00000018901YC9. 00000018902YC7. 00000018903YC5. 00000018904YC3. 00000018905YC0. 00000018957YC1. 00000019048YC8. 00000019049YC6. 00000019126YC2. 00000019127YC0. 00000019255YC9. 00000019256YC7. 00000019257YC5. 00000019401YC9. 00000019402YC7. 00000019403YC5. 00000019404YC3. 000000208703HM. 00000195292HM8. 00000195293HM6. 00000195294HM4. 00000196294HM3. 00000196295HM0. 00000196296HM8. 00000196312HM3. 00000196313HM1. 00000196314HM9. 00000196638HM1. 00000197187HM8. 00000197346HM0. 00000197355HM1. 00000197356HM9. 00000197785HM9. 00000197786HM7. 00000197787HM5. 00000197788HM3. 00000197789HM1. 00000197790HM9. 00000197809HM7. 00000197810HM5. 00000197811HM3. 00000198797HM3. 00000198798HM1. 00000198799HM9. 00000198800HM5. 00000198801HM3. 00000198802HM1. 00000199556HM2. 00000199557HM0. 00000199558HM8. 00000199559HM6. 00000200149HM3. 00000200153HM5. 00000200154HM3. 00000200161HM8. 00000200690HM6. 00000200691HM4. 00000200692HM2. 00000201095HM7. 00000201099HM9. 00000201100HM5. 00000201115HM3. 00000201560HM0. 00000201561HM8. 00000201562HM6. 00000201563HM4. 00000201576HM6. 00000201577HM4. 00000201578HM2. 00000201596HM4. 00000201597HM2. 00000202433HM9. 00000202434HM7. 00000202435HM4. 00000202436HM2. 00000202620HM1. 00000202624HM3. 00000202625HM0. 00000202626HM8. 00000202627HM6. 00000202628HM4. 00000203596HM2. 00000203600HM2. 00000203601HM0. 00000203602HM8. 00000203603HM6. 00000204144HM0. 00000204145HM7. 00000204163HM0. 00000204164HM8. 00000204197HM8. 00000204198HM6. 00000204199HM4. 00000205488HM0. 00000205489HM8. 00000205496HM3. 00000205497HM1. 00000205498HM9. 00000205936HM8. 00000205937HM6. 00000205938HM4. 00000205939HM2. 00000205962HM4. 00000205963HM2. 00000205964HM0. 00000205965HM7. 00000205966HM5. 00000205967HM3. 00000205998HM8. 00000205999HM6. 00000206848HM4. 00000206849HM2. 00000207034HM0. 00000207035HM7. 00000207361HM7. 00000207362HM5. 00000207741HM0. 00000207742HM8. 00000208226HM1. 00000208227HM9. 00000208228HM7. 00000208229HM5. 00000208230HM3. 00000208253HM5. 00000208691HM6. 00000208692HM4. 00000208701HM3. 00000208702HM1. 00000208703HM9. 00000208704HM7. 00000209561HM0. 00000209578HM4. 00000209579HM2. 00000209611HM3. 00000209612HM1. 00000210016HM2. 00000210017HM0. 00000214731HM2. 00000214734HM6. Model 5377708-560, serial numbers: 00000019027YC2. 00000019577YC6. 00000019578YC4. 00000019579YC2. 00000019651YC9. 00000019652YC7. 00000019808YC5. 00000019809YC3. 00000019910YC9. 00000019911YC7. 00000020098YC0. 00000020152YC5. 00000020153YC3. 00000020283YC8. 00000020284YC6. 00000020456YC0. 00000020457YC8. 00000020458YC6. 00000020471YC9. 00000020522YC9. 00000020523YC7. 00000020711YC8. 00000020712YC6. 00000020713YC4. 00000020757YC1. 00000020758YC9. 00000020837YC1. 00000020942YC9. 00000020943YC7. 00000021158YC1. 00000021159YC9. 00000021160YC7. 00000021264YC7. 00000021270YC4. 00000021271YC2. 00000021272YC0. 00000021666YC3. 00000021667YC1. 00000021668YC9. 00000021669YC7. 00000021670YC5. 00000021767YC9. 00000021768YC7. 00000021769YC5. 00000021880YC0. 00000021881YC8. 00000022160YC6. 00000022161YC4. 00000022162YC2. 00000022163YC0. 00000022259YC6. 00000022260YC4. 00000022261YC2. 00000022352YC9. 00000022353YC7. 00000022457YC6. 00000022458YC4. 00000022459YC2. 00000022460YC0. 00000022705YC8. 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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Call 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
DESIGN: Software Design
Action An 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 Commerce 946
Distribution Worldwide 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 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, LLC
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