Device Recall GE PET/CT System 의 리콜

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 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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 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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

Radiology Devices

2

No

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 .

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.