FDAFDA · Alimentos y medicamentos·N.º oficial Z-0023-2014
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Publicado el 23 de octubre de 2013 · Inicio del retiro: 26 de marzo de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- 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.
- Lote
- 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 00000310013HM8 00000313520HM9 00000320004HM5 00000322646HM1 00000297489HM7 00000302022HM9 00000318966HM9 00000322993HM7 00000040368YC3 00000327365HM3 00000040081YC2 00000041147YC0 00000042968YC8 00000044150YC1 00000044861YC3 00000045907YC3 00000047740YC6 00000044399YC4 00000045314YC2 00000328079HM9 00000325768HM0 00000027396YC1 00000033407YC8 00000325766HM4 00000299338HM4 00000295308HM1 00000030752YC0 00000312781HM8 00000319291HM1 00000319292HM9 00000322992HM9 00000325769HM8 00000310566HM5 00000311079HM8 00000042014YC1 00000048323YC0 00000048013YC7 00000048014YC5 00000048315YC6 00000048317YC2 00000039804YC0 00000040083YC8 00000041145YC4 00000041828YC5 00000042806YC0 00000042965YC4 00000043220YC3 00000043904YC2 00000044524YC7 00000044858YC9 00000045315YC9 00000045317YC5 00000045603YC8 00000043483YC7 00000044862YC1 00000045316YC7 00000045607YC9 00000045909YC9 00000046475YC0 00000046726YC6 00000046727YC4 00000047521YC0 00000296966HM5 00000038151YC7 00000311081HM4 00000311879HM1 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 00000040820YC3 00000040821YC1 00000040822YC9 00000041143YC9 00000041144YC7 00000042010YC9 00000041148YC8 00000042012YC5 00000043479YC5 00000042449YC9 00000042453YC1 00000042454YC9 00000042456YC4 00000042966YC2 00000043223YC7 00000043221YC1 00000044149YC3 00000045312YC6 00000045910YC7 00000045912YC3 00000046275YC4 00000045911YC5 00000046471YC9 00000046472YC7 00000046724YC1 00000047059YC1 00000047327YC2 00000047329YC8 00000047518YC6 00000047519YC4 00000321688HM4 00000321949HM0 00000320786HM7 00000320787HM5 00000321689HM2 00000321950HM8 00000327464HM4 00000307765HM8 00000308946HM3 00000308948HM9 00000311080HM6 00000316555HM2 00000318136HM9 00000296969HM9 00000297490HM5 00000301345HM5 00000302020HM3 00000296967HM3 00000301348HM9 00000302023HM7 00000042455YC6 00000042805YC2 00000042964
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.