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U.S. Department of Health and Human Services

Class 2 Device Recall GE, Optima CT660

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 Class 2 Recall
GE, Optima CT660
see related information
Date Posted October 17, 2013
Recall Status1 Terminated on December 05, 2013
Recall Number Z-0023-2014
Recall Event ID 65958
Premarket Notification
510(K) Number
K110227 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Code Information Mfg Lot or Serial # 00000426724CN1 00000429656CN2 00000429809CN7 00000430378CN0 00000430460CN6 00000430480CN4 00000430489CN5 00000430646CN0 00000430650CN2 00000430651CN0 00000430737CN7 00000430795CN5 00000430813CN6 00000430951CN4 00000431016CN5 00000431035CN5 00000431141CN1 00000431269CN0 00000431307CN8 00000431350CN8 00000431506CN5 00000425485CN0 00000424498CN4 00000427441CN1 00000428100CN2 00000429970CN7 00000430427CN5 00000431140CN3 00000431442CN3 00000425128CN6 00000425032CN0 00000428566CN4 00000431662CN6 00000431604CN8 00000431721CN0 00000431708CN7 00000428762CN9 00000428780CN1 00000429600CN0 00000429658CN8 00000429818CN8 00000429877CN4 00000430132CN1 00000430186CN7 00000430264CN2 00000430282CN4 00000430296CN4 00000043742YC6 00000043902YC6 00000045606YC1 00000046476YC8 00000429917CN8 00000037723YC4 00000043482YC9 00000046473YC5 00000042457YC2 00000326336HM5 00000026193YC3 00000328747HM1 00000304641HM4 00000304751HM1 00000305380HM8 00000305871HM6 00000308319HM3 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00000328746HM3 00000310567HM3 00000316768HM1 00000316770HM7 00000318137HM7 00000315021HM6 00000318138HM5 00000318965HM1 00000042451YC5 00000278510HM3 00000322643HM8 00000043480YC3 00000046474YC3 00000047058YC3 00000040616YC5 00000310612HM7 00000311876HM7 00000325426HM5 00000047631YC7 00000047738YC0 00000327465HM1 00000327467HM7 00000037908YC1 00000042011YC7 00000042967YC0 00000042969YC6 00000044857YC1 00000044859YC7 00000046276YC2 00000048318YC0 00000045064YC3 00000045318YC3 00000044398YC6 00000027886YC1 00000034385YC5 00000031032YC6 00000026850YC8 00000037592YC3 00000038154YC1 00000039342YC1 00000039808YC1 00000043222YC9 00000047061YC7 00000047520YC2 00000048010YC3 00000048316YC4 00000048321YC4 00000048526YC8 00000048625YC8 00000048320YC6 00000037593YC1 00000037909YC9 00000038153YC3 00000038739YC9 00000039000YC5 00000039001YC3 00000039002YC1 00000039343YC9 00000039344YC7 00000039601YC0 00000039806YC5 00000039807YC3 00000039809YC9 00000040366YC7 00000040367YC5 00000040819YC5 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00000310014HM6 00000317418HM2 00000034384YC8 00000315827HM6 00000045608YC7 00000044640YC1 00000430273CN3 00000305869HM0 00000430875CN5 00000324510HM7 00000329532HM6 00000312779HM2 00000039003YC9 00000038738YC1 00000044152YC7 00000308321HM9 00000310568HM1 00000034790YC6 00000031572YC1 00000293945HM2 00000321953HM2 00000322642HM0 00000325265HM7 00000325266HM5 00000037282YC1 00000038740YC7 00000040818YC7 00000041827YC7 00000042804YC5 00000043481YC1 00000043740YC0 00000044526YC2 00000044638YC5 00000044639YC3 00000044641YC9 00000044643YC5 00000044860YC5 00000045065YC0 00000315828HM4 00000315829HM2 00000316790HM5 00000296971HM5 00000044644YC3 00000045066YC8 00000316769HM9 00000320005HM2 00000296968HM1 00000047630YC9 00000048012YC9 00000041829YC3 00000042450YC7
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 26, 2013. The letter was addressed to Director of Radiology, Emergency Medicine Physicians and Radiologic Technologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.
Quantity in Commerce 380 (52 US & 328 OUS)
Distribution Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.
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 MEDICAL SYSTEMS, LLC
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