Class 2 Device Recall GE BrightSpeed CT

• Date Initiated by Firm: September 03, 2010
• Date Posted: November 15, 2010
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-0369-2011
• Recall Event ID: 56814
• 510(K)Number: 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 WI 53188-1615
• 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: 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 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) Database: 510(K)s with Product Code = JAK; 510(K)s with Product Code = JAK