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U.S. Department of Health and Human Services

Class 2 Device Recall GE PET/CT System

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  Class 2 Device Recall GE PET/CT System see related information
Date Initiated by Firm February 10, 2016
Create Date March 04, 2016
Recall Status1 Terminated 3 on September 21, 2016
Recall Number Z-1050-2016
Recall Event ID 73248
510(K)Number K040172  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Discovery ST, , 2339985
LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
Code Information Mfg Lot or Serial # System ID 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000294153CN2 0910212097 00000309306CN9 0910212101 00000309960CN3 0910212104 00000309960CN3 0910212104 00000311052CN5 0910212105 00000321402CN0 0910212106 00000321402CN0 0910212106 00000337340CN4 0910212115 00000337340CN4 0910212115 00000337340CN4 0910212115 00000297003CN6 0910213064 00000313645CN4 0910213070 00000301209CN3 0910215018 00000313097CN8 0910216036 00000337344CN6 0910216041 00000297460CN8 AH1410CT06 00000325191CN5 AH5362CT02 00000310728CN1 110037CT01 00000310728CN1 110037CT01 00000299935CN7 190020CT03 00000311058CN2 190052CT06 00000297386CN5 190059CT04 00000311058CN2 190052CT06 00000311426CN1 030018CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000327271CN3 10026 00000346702CN4 1350651 00000310682CN0 2850998 00000310682CN0 2850998 00000327815CN7 CT327815CN7 00000332075CN1 BG4037CT01 UNK23399850000 BG4037CT01 00000316663CN4 BG4042CT01 00000316663CN4 BG4042CT01 00000327081CN6 BG4608CT01 00000314635CN4 BG4600CT01 00000357475CN3 CM1007CT02 00000357475CN3 CM1007CT02 00000357475CN3 CM1007CT02 00000361978CN0 082445020003 00000361978CN0 082445020003 00000361978CN0 082445020003 00000352887CN4 082445030003 00000347756CN9 082445100008 00000347756CN9 082445100008 00000309961CN1 082445150001 00000336259CN7 082445150008 00000359854CN7 082445160007 00000354676CN9 082445250002 00000294148CN2 HLGSCTD10002 00000294148CN2 HLGSCTD10002 00000299483CN8 082421111101 00000334898CN4 082421140150 00000322331CN0 082421160145 00000298653CN7 082421030115 00000333002CN4 082421030162 00000295411CN3 082421030340 00000299934CN0 082421040093 00000295644CN9 082421040096 00000299483CN8 082421111101 00000308733CN5 082421040103 00000299951CN4 082421030354 00000299951CN4 082421030354 00000299951CN4 82421030354 00000322333CN6 082421040120 00000295409CN7 082421050034 00000323331CN9 082421050038 00000343124CN4 082421060040 00000317099CN0 082421070116 00000330529CN9 082421070130 00000297900CN3 082421070368 00000323328CN5 082421080059 00000320550CN7 082421100258 00000323310CN3 082421100259 00000322857CN4 082421100260 00000322857CN4 082421100260 00000335318CN2 082421100265 00000336002CN1 082421130067 00000329307CN3 082421160152 00000342614CN5 082421160155 00000295117CN6 082421210084 00000319305CN9 082421220038 00000297900CN3 082421070368 00000331165CN1 082421010103 00000335317CN4 082421010157 00000333000CN8 082421020090 00000287474CN1 082421130055 00000295411CN3 082421030340 00000308614CN7 082421130065 00000336002CN1 082421130067 00000314492CN0 082421140117 00000356887CN0 082421220038 00000336001CN3 082421220044 00000323308CN7 082421020070 00000332999CN2 082421140145 00000295644CN9 082421040096 00000346880CN8 2532905LIG16 00000337342CN0 374521381CT 00000337342CN0 374521381CT 00000295118CN4 DK1018CT01 00000297992CN0 DK1025CT02 00000313915CN1 11390744CT 00000313915CN1 11390744CT 00000323858CN1 FI1003CT03 00000295643CN1 FI1017CT02 00000323858CN1 FI1003CT03 00000295643CN1 FI1017CT02 00000304685CN1 A4167313 00000319308CN3 B4195716 00000313650CN4 C6010809 UNK23399850001 GOLD001266 00000298318CN7 GOLD010093 00000310120CN1 X966077004 00000313650CN4 C6010809 00000324460CN5 M1020808 00000326112CN0 M1279722 00000311808CN0 M2312304 00000293009CN7 M2322212 00000307022CN4 M23737001 00000311059CN0 M2486504 00000305523CN3 M2800910 00000317193CN1 M2848414 00000298344CN3 M40345153 00000298327CN8 M4047054 00000298318CN7 GOLD010093 00000320672CN9 M4160064 00000303583CN9 M4163021 00000324985CN1 M4174504 00000298659CN4 M4180123 00000310268CN8 M4191025 00000326084CN1 M4192518 00000325672CN4 M4198036 00000326326CN6 M4198185 00000304683CN6 M4215536 00000336000CN5 M4409416 00000336003CN9 M4491526 00000309305CN1 M4491923 00000319062CN6 M4497247 00000302751CN3 M4516011 00000293499CN0 M5481223 00000315232CN9 M5647104 00000326111CN2 M8050904 00000296278CN5 M9202219 00000297389CN9 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GOLD002151 00000319948CN6 GOLD002182 00000293010CN5 GOLD002151 00000297427CN7 GOLD001604 00000319948CN6 GOLD002182 00000309522CN1 GOLD001588 00000296977CN2 410014CT01 00000288652CN1 CC0618CT02 00000313361CN8 HC0399CT01 00000301205CN1 HC1627CT04 00000310261CN3 HC2252CT01 00000294145CN8 HC3076CT01 00000302750CN5 HC3314CT02 00000327818CN1 HC4438CT01 00000311056CN6 PC1268CT03 00000317102CN2 PC1401CT01 00000302754CN7 PC7479CT02 00000299235CN2 PC8118CT03 00000294146CN6 UC1590CT01 00000296977CN2 410014CT01 00000310261CN3 HC2252CT01 00000294146CN6 UC1590CT01 00000302754CN7 PC7479CT02 00000309302CN8 HC3428CT02 00000310261CN3 HC2252CT01 00000302754CN7 PC7479CT02 00000305953CN2 05252CTS01 00000305953CN2 05252CTS01 00000294146CN6 UC1590CT01 00000327079CN0 GP1036CT01 00000297599CN3 0828210042 00000309521CN3 0828210045 00000322338CN5 0828210046 00000330530CN7 0828210047 00000323258CN4 0828210094 00000323258CN4 0828210094 00000325192CN3 HU1137CT02 00000319061CN8 Unlocated 00000317789CN6 GOLD010275 00000313648CN8 HU1008CT02 00000297465CN7 HU1039CT03 00000297465CN7 HU1039CT03 00000300567CN5 083021840009012 00000331758CN3 08302100210134X 00000342119CN5 083021042101703 00000345300CN8 083021242100044 00000307945CN6 083021592012120 00000332732CN7 083021602101433 00000311812CN2 083021802100123 00000331758CN3 08302100210134X 00000336854CN5 083021824542213 00000322337CN7 083021842100841 00000336854CN5 083021824542213 00000333821CN7 IR1050CT02 00000330534CN9 IL1000CT01 00000314489CN6 A5816714 00000298365CN8 A206873404 00000294150CN8 A224457303 00000314489CN6 A5816714 00000298364CN1 A5109820 00000329300CN8 A5114983 UNK23399850002 A5127399 00000297387CN3 A5158020 00000298788CN1 A5248810 00000297006CN9 A5279809 00000297467CN3 A5315535 00000305241CN2 A5333021 00000325670CN8 A5364424 00000318594CN9 A5366613 00000297991CN2 A5375119 00000297991CN2 A5375119 00000298788CN1 A5248810 00000308141CN1 A5630204 00000314489CN6 A5816714 00000296974CN9 A5824009 00000316659CN2 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419584CT 00000318591CN5 309680CT 00000317568CN4 214647LS16 00000336801CN6 936538PERC 00000318591CN5 309680CT 00000316660CN0 402887CT16 00000293034CN5 419584CT 00000317568CN4 214647LS16 00000294765CN3 251368ACT 00000316259CN1 210351MSDLS 00000311810CN6 763588SPCT 00000328245CN6 706378LS16 00000294345CN4 SMGCT15 00000296976CN4 38826196CTOCC 00000296976CN4 38826196CTOCC  00000323258CN #N/A 
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
FDA Determined
Cause 2		 Labeling design
Action GE Healthcare sent an Urgent Medical Device Correction letter " GEHC Ref# 25467-ABT or 25467" dated February 12, 2016, to all affected consignees . The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, & Radiologist/Cardiologist. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to ensure that the organization that service their equipment uses the latest version of the Service Manual to maintain the safe and proper performance of their medical device. For questions call in the United States: 1-800-437-1171 or your local GE Healthcare Service Representative. For questions regarding this recall call 262-513-4122.
Quantity in Commerce 522
Distribution Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
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 = KPS and Original Applicant = GE MEDICAL SYSTEMS
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